97. Ulcerative colitis Clinical trials / Disease details
Clinical trials : 2,527 / Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-002549-13-NO (EUCTR) | 07/03/2022 | 24/11/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 2 | EUCTR2021-002549-13-HR (EUCTR) | 24/02/2022 | 28/02/2022 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 3 | NCT05186623 (ClinicalTrials.gov) | February 5, 2022 | 22/12/2021 | Prediction Model for Response to Biologics and Small Molecular Agent for UC | Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data | Ulcerative Colitis | Drug: Vedolizumab, Ustekinumab, or Tofacitinib | Asan Medical Center | NULL | Recruiting | 18 Years | 79 Years | All | 300 | Korea, Republic of | |
| 4 | EUCTR2021-001644-10-HU (EUCTR) | 04/02/2022 | 15/12/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 5 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 6 | EUCTR2021-001644-10-IT (EUCTR) | 21/12/2021 | 17/09/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis(EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 7 | EUCTR2021-002549-13-LT (EUCTR) | 02/12/2021 | 06/09/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 8 | EUCTR2021-002549-13-SK (EUCTR) | 02/12/2021 | 24/08/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 9 | NCT05084261 (ClinicalTrials.gov) | November 30, 2021 | 20/9/2021 | An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: BT051 up to 3200 mg;Drug: Matching Placebo | Bacainn Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 44 | Phase 1 | United States;Georgia;Moldova, Republic of;Poland;Ukraine |
| 10 | EUCTR2021-001644-10-ES (EUCTR) | 30/11/2021 | 12/08/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 11 | NCT04985968 (ClinicalTrials.gov) | November 24, 2021 | 22/7/2021 | The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | Ulcerative Colitis | Drug: Cobitolimod 250 mg;Drug: Cobitolimod 500 mg;Drug: Placebo | InDex Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 440 | Phase 3 | Hungary |
| 12 | EUCTR2018-001605-93-HU (EUCTR) | 22/11/2021 | 05/05/2020 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 13 | EUCTR2021-002549-13-IT (EUCTR) | 22/11/2021 | 19/10/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod | INDEX PHARMACEUTICALS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 14 | NCT05088369 (ClinicalTrials.gov) | November 2021 | 12/10/2021 | Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201 | A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults) | Ulcerative Colitis;Crohn's Disease | Drug: HM201;Drug: Placebo | Syneos Health | Himuka AM Pharma Corp. | Not yet recruiting | 18 Years | 55 Years | All | 68 | Early Phase 1 | NULL |
| 15 | JPRN-jRCT2041200098 | 28/10/2021 | 02/02/2021 | A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | -Ustekinumab Dose Based on BSA and Body Weight As per BSA and body weight Ustekinumab will be administered SC and IV. Induction Period (I):Ustekinumab Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) -Matching Placebo Placebo will be administered subcutaneously. Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) | Nishikawa Kazuko | NULL | Recruiting | >= 2age old | < 18age old | Both | 90 | Phase 3 | United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan |
| 16 | NCT04499495 (ClinicalTrials.gov) | October 25, 2021 | 31/7/2020 | Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea | A Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea | Ulcerative Colitis | Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA) | Ferring Pharmaceuticals | NULL | Recruiting | 15 Years | N/A | All | 15000 | Korea, Republic of | |
| 17 | EUCTR2021-002549-13-DE (EUCTR) | 20/10/2021 | 28/06/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Norway;New Zealand;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia | ||
| 18 | EUCTR2021-000091-11-CZ (EUCTR) | 20/10/2021 | 22/04/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Georgia | ||
| 19 | NCT04779307 (ClinicalTrials.gov) | October 19, 2021 | 1/3/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Drug: Vedolizumab | Takeda | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 3 | United States |
| 20 | JPRN-jRCT2071210030 | 19/10/2021 | 31/05/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm. Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee | Shikamura Mitsuhiro | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan |
| 21 | NCT05061446 (ClinicalTrials.gov) | October 16, 2021 | 20/9/2021 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 20 Years | 80 Years | All | 96 | Phase 2 | Japan |
| 22 | EUCTR2020-004300-34-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - NA | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 23 | NCT05058417 (ClinicalTrials.gov) | October 1, 2021 | 16/9/2021 | Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis | Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: Empagliflozin 10 MG | Sadat City University | NULL | Recruiting | 18 Years | 60 Years | All | 50 | Phase 2 | Egypt |
| 24 | NCT04767984 (ClinicalTrials.gov) | September 24, 2021 | 23/2/2021 | Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis | A Randomized and Placebo-Controlled Phase II Trial Targeting Dominant-Negative Missense Mutant P53 by Atorvastatin for Reducing the Risk of Longstanding Ulcerative Colitis-Associated Cancer | Colorectal Carcinoma;Ulcerative Colitis | Drug: Atorvastatin Calcium;Procedure: Biospecimen Collection;Drug: Placebo Administration | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | 70 Years | All | 70 | Phase 2 | United States |
| 25 | EUCTR2021-002549-13-HU (EUCTR) | 24/09/2021 | 23/07/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 26 | JPRN-jRCTs031210326 | 21/09/2021 | 21/09/2021 | Evaluation of biomarkers in BF treatment | A multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness ofserum biomarker measurement for active ulcerative colitis - BF-LRG | Ulcerative colitis Ulcerative colitis | Budesonide foam was administered as a study drug | Matsuoka Katsuyoshi | EA Pharma Co., Ltd. | Recruiting | >= 16age old | Not applicable | Both | 20 | N/A | Japan |
| 27 | EUCTR2020-004300-34-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 28 | JPRN-jRCT2051210087 | 17/09/2021 | 22/09/2021 | Safety and pharmacokinetics study in healthy Japanese volunteers | A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers | Ulcerative colitis | Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen. | Owada Yasuko | NULL | Pending | >= 20age old | <= 45age old | Male | 48 | Phase 1 | Japan |
| 29 | JPRN-jRCT2011210030 | 14/09/2021 | 30/08/2021 | Phase 2 Dose-finding UC Study | A 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Expedition Lead-in | Ulcerative Colitis, Colitis, Ulcerative, IBD | - Brazikumab low dose: IV brazikumab 720 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Brazikumab high-dose: IV brazikumab 1440 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Placebo: IV placebo at Week 0 (Day 1), Week 2, and Week 6 followed by SC placebo every 4 weeks beginning at Week 10 | Hibi Kazushige | NULL | Recruiting | >= 18age old | <= 80age old | Both | 21 | Phase 2 | India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan |
| 30 | EUCTR2021-000091-11-HU (EUCTR) | 13/09/2021 | 17/04/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Georgia | ||
| 31 | EUCTR2021-002549-13-SE (EUCTR) | 07/09/2021 | 16/06/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 32 | JPRN-jRCT2071210052 | 23/08/2021 | 19/08/2021 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy inModerately to Severely Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-WeekDose-Ranging Study to Assess the Efficacy and Safety of Etrasimod inJapanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | Eligible subjects will be randomized (1:1:1ratio) to receive either etrasimod (dose A), etrasimod (dose B), or matching placebo (once daily) in a double-blind fashion for 12 weeks | Tanabe Masakazu | NULL | Recruiting | >= 20age old | <= 80age old | Both | 96 | Phase 2 | Japan |
| 33 | EUCTR2020-004300-34-HR (EUCTR) | 18/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 34 | EUCTR2021-000091-11-PL (EUCTR) | 06/08/2021 | 20/05/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia | ||
| 35 | EUCTR2020-004300-34-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 36 | EUCTR2018-002135-19-FR (EUCTR) | 16/07/2021 | 02/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 37 | EUCTR2020-000609-10-DK (EUCTR) | 06/07/2021 | 23/09/2020 | A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patients | A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study | A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch. MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Repomol INN or Proposed INN: Molgramostim Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: Metronidazole Trade Name: Fosfomycin Product Name: Infectofos INN or Proposed INN: Fosfomycin disodium Other descriptive name: FOSFOMYCIN DISODIUM | Center for Surgical Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 1;Phase 2 | Denmark | ||
| 38 | EUCTR2019-003113-34-SK (EUCTR) | 29/06/2021 | 27/04/2021 | Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany | ||
| 39 | EUCTR2020-004300-34-LT (EUCTR) | 25/06/2021 | 21/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 40 | NCT04372108 (ClinicalTrials.gov) | June 24, 2021 | 30/4/2020 | A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis | An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab;Drug: Other Biologic Therapies | Janssen Scientific Affairs, LLC | NULL | Recruiting | 18 Years | N/A | All | 1056 | United States | |
| 41 | EUCTR2020-004300-34-ES (EUCTR) | 02/06/2021 | 01/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 42 | EUCTR2020-004300-34-GR (EUCTR) | 01/06/2021 | 29/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 43 | NCT04898530 (ClinicalTrials.gov) | May 15, 2021 | 13/5/2021 | Diet Patterns in IBD in Central Texas | A Cross-sectional Assessment of Diet in Patients With IBD in Central Texas | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Other: NO INTERVENTION | University of Texas at Austin | NULL | Recruiting | 18 Years | N/A | All | 500 | United States | |
| 44 | NCT04607837 (ClinicalTrials.gov) | April 19, 2021 | 23/10/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 18 Years | 80 Years | All | 162 | Phase 2 | United States;Australia;Belarus;Belgium;Bulgaria;Canada;Czechia;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Portugal;Russian Federation;Spain;Ukraine |
| 45 | EUCTR2020-003507-34-BG (EUCTR) | 02/04/2021 | 10/02/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 46 | NCT04818788 (ClinicalTrials.gov) | April 1, 2021 | 20/3/2021 | Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis | Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy | Ulcerative Colitis | Drug: Biological Drug | Assiut University | NULL | Not yet recruiting | 18 Years | 55 Years | All | 24 | NULL | |
| 47 | NCT04630028 (ClinicalTrials.gov) | March 17, 2021 | 13/11/2020 | A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 90 | Phase 3 | United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom |
| 48 | EUCTR2020-000047-31-PL (EUCTR) | 13/03/2021 | 15/07/2021 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Moldova, Republic of | ||
| 49 | EUCTR2016-004676-22-FR (EUCTR) | 09/03/2021 | 26/01/2021 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 50 | EUCTR2020-003507-34-PT (EUCTR) | 26/02/2021 | 04/01/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | United States;Portugal;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 51 | EUCTR2019-004224-38-DE (EUCTR) | 25/02/2021 | 20/10/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 52 | EUCTR2020-002833-13-PL (EUCTR) | 24/02/2021 | 19/11/2020 | A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Georgia;Netherlands | ||
| 53 | EUCTR2020-003507-34-HU (EUCTR) | 11/02/2021 | 29/12/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 54 | EUCTR2020-000047-31-DE (EUCTR) | 11/02/2021 | 17/08/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 55 | EUCTR2020-003507-34-IT (EUCTR) | 09/02/2021 | 30/08/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 56 | EUCTR2020-003006-31-IT (EUCTR) | 08/02/2021 | 02/08/2021 | Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis | Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis - ASPIRE | Ulcerative colitis and concomitant peripheral arthritis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOFACINITIB Product Code: [TOFACINITIB] INN or Proposed INN: TOFACINITIB | FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Italy | ||
| 57 | NCT04750135 (ClinicalTrials.gov) | February 7, 2021 | 7/2/2021 | Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis | Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: metformin 500 mg TID Oral Tablet;Drug: Placebo | National Hepatology & Tropical Medicine Research Institute | NULL | Not yet recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | Egypt |
| 58 | EUCTR2020-002833-13-NL (EUCTR) | 05/02/2021 | 29/10/2020 | A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Poland;Ukraine;Georgia;Netherlands | ||
| 59 | EUCTR2020-003507-34-FR (EUCTR) | 02/02/2021 | 16/12/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | United States;Portugal;Czechia;Spain;Russian Federation;Israel;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 60 | EUCTR2019-004224-38-HU (EUCTR) | 30/12/2020 | 22/10/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 61 | NCT04706793 (ClinicalTrials.gov) | December 25, 2020 | 11/1/2021 | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Active, not recruiting | 16 Years | 80 Years | All | 42 | Phase 3 | Japan |
| 62 | JPRN-jRCT2071200080 | 25/12/2020 | 13/01/2021 | ELEVATE UC 40 JAPAN: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Japanese Subjects | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | The investigational drug and the placebo are an oral tablet. The investigational drug is APD334 (etrasimod). | IQVIA Services Japan K.K. ICCC: | NULL | Not Recruiting | >= 16age old | <= 80age old | Both | 35 | Phase 3 | Japan |
| 63 | NCT04721873 (ClinicalTrials.gov) | December 18, 2020 | 19/1/2021 | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial | Colitis, Ulcerative;Obesity | Drug: Phentermine-Topiramate;Drug: Placebo | University of California, San Diego | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | United States |
| 64 | NCT04749576 (ClinicalTrials.gov) | December 15, 2020 | 9/12/2020 | Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: saffron supplement for IBD | Howard University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | N/A | United States |
| 65 | NCT03414788 (ClinicalTrials.gov) | December 7, 2020 | 8/1/2018 | Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease | PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS | Inflammatory Bowel Disease | Biological: PF 06687234;Biological: [124I]IB PF 06687234 | Pfizer | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 66 | EUCTR2020-001398-59-HR (EUCTR) | 02/12/2020 | 07/12/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 67 | EUCTR2020-000047-31-BG (EUCTR) | 25/11/2020 | 08/10/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of | ||
| 68 | NCT04883840 (ClinicalTrials.gov) | October 22, 2020 | 6/5/2021 | Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis | Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis | Ulcerative Colitis | Drug: Rosuvastatin 10mg | Universitaire Ziekenhuizen Leuven | Vlaams Instituut Biotechnologie (VIB) | Recruiting | 18 Years | 70 Years | All | 220 | Phase 2/Phase 3 | Belgium |
| 69 | EUCTR2020-000047-31-FR (EUCTR) | 07/10/2020 | 13/05/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of | ||
| 70 | NCT04577794 (ClinicalTrials.gov) | October 5, 2020 | 30/9/2020 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: GLPG3970;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 64 Years | All | 31 | Phase 2 | Georgia;Moldova, Republic of;Poland;Ukraine |
| 71 | NCT04535882 (ClinicalTrials.gov) | October 1, 2020 | 28/8/2020 | Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD | Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis | LRG Levels | Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels | Showa Inan General Hospital | NULL | Recruiting | N/A | N/A | All | 125 | Japan | |
| 72 | NCT03996369 (ClinicalTrials.gov) | September 15, 2020 | 21/6/2019 | Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 16 Years | 80 Years | All | 354 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Thailand;Turkey;Ukraine;United Kingdom |
| 73 | NCT04338204 (ClinicalTrials.gov) | September 14, 2020 | 4/4/2020 | Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden | Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN) | Ulcerative Colitis | Drug: tofacitinib | Pfizer | NULL | Recruiting | 18 Years | 99 Years | All | 120 | Sweden | |
| 74 | EUCTR2020-000659-11-PL (EUCTR) | 10/09/2020 | 23/07/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with ulcerative colitis | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Georgia;Moldova, Republic of | ||
| 75 | EUCTR2020-000047-31-HU (EUCTR) | 09/09/2020 | 07/07/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 76 | NCT04205643 (ClinicalTrials.gov) | September 2, 2020 | 18/12/2019 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: CT-P13 SC (Infliximab);Other: Placebo SC | Celltrion | NULL | Active, not recruiting | 18 Years | 75 Years | All | 548 | Phase 3 | Poland |
| 77 | JPRN-jRCTs031200103 | 01/09/2020 | 01/09/2020 | Alginate combined fecal microbiota transplantation for ulcerative colitis | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | Ulcerative colitis Ulcerative colitis | A-FMT plus algin acid therapy arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take algin acid two times a day every single day. A-FMT plus placebo arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take Placebo two times a day every single day. | Ishikawa Dai | NULL | Recruiting | >= 20age old | Not applicable | Both | 60 | N/A | Japan |
| 78 | EUCTR2019-004208-37-BE (EUCTR) | 03/08/2020 | 04/03/2020 | Statins for treating ulcerative colitis through GI microbiome | Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy | There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Rosuvastatine EG Product Name: rosuvastatin INN or Proposed INN: rosuvastatin Other descriptive name: ROSUVASTATIN CALCIUM | UZ Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Belgium | ||
| 79 | EUCTR2020-000047-31-GB (EUCTR) | 03/08/2020 | 20/04/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 80 | EUCTR2019-003596-19-DE (EUCTR) | 29/07/2020 | 29/07/2020 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India | ||
| 81 | EUCTR2018-003986-33-PT (EUCTR) | 06/07/2020 | 28/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Thailand;Spain | ||
| 82 | NCT04457960 (ClinicalTrials.gov) | July 1, 2020 | 1/7/2020 | A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433 | Healthy;Colitis, Ulcerative | Drug: JNJ-66525433;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 60 Years | All | 140 | Phase 1 | Georgia;Germany;Moldova, Republic of |
| 83 | EUCTR2019-003596-19-IT (EUCTR) | 26/06/2020 | 17/06/2021 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. - CESSA | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg idrocortisone acetato in supposta con applicatore per supposte Sephure Product Code: [90 mg idrocortisone acetato in supposta con appli INN or Proposed INN: IDROCORTISONE ACETATO | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Russian Federation;Germany;Italy;India | ||
| 84 | EUCTR2019-003849-15-HR (EUCTR) | 05/06/2020 | 20/11/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 85 | EUCTR2019-003849-15-CZ (EUCTR) | 28/05/2020 | 16/03/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Belarus;Serbia;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of | ||
| 86 | JPRN-JapicCTI-194980 | 22/5/2020 | 30/09/2019 | A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC. | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 1000 | Phase 2-3 | Japan, Asia except Japan, North America, Europe | |
| 87 | EUCTR2018-001605-93-DE (EUCTR) | 20/05/2020 | 04/06/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 88 | EUCTR2019-000733-39-FR (EUCTR) | 14/05/2020 | 20/02/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 89 | NCT04272307 (ClinicalTrials.gov) | May 14, 2020 | 14/2/2020 | MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach. | MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach. | Inflammatory Bowel Diseases;Colitis;Ulcerative | Biological: Blood samples;Procedure: Stool samples;Procedure: Colorectal biopsies | University Hospital, Bordeaux | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | 18 Years | N/A | All | 40 | France | |
| 90 | EUCTR2019-003849-15-ES (EUCTR) | 12/05/2020 | 28/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 91 | EUCTR2019-003113-34-NO (EUCTR) | 04/05/2020 | 21/01/2020 | Ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Russian Federation;Bulgaria;Germany;Norway | ||
| 92 | EUCTR2018-003278-28-BG (EUCTR) | 22/04/2020 | 23/05/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of | ||
| 93 | EUCTR2019-000733-39-GB (EUCTR) | 16/04/2020 | 31/01/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 94 | EUCTR2019-003849-15-IT (EUCTR) | 15/04/2020 | 17/06/2021 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis - NA | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima (CT-P13) Product Code: [Remsima (CT-P13)] INN or Proposed INN: INFLIXIMAB Product Name: CT-P13 Product Code: [CT-p13] INN or Proposed INN: INFLIXIMAB | CELLTRION INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 95 | EUCTR2018-003986-33-AT (EUCTR) | 07/04/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 96 | EUCTR2019-003849-15-GR (EUCTR) | 03/04/2020 | 02/04/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 97 | EUCTR2019-003849-15-FR (EUCTR) | 03/04/2020 | 03/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 98 | EUCTR2019-003849-15-BG (EUCTR) | 03/04/2020 | 07/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of | ||
| 99 | NCT04332328 (ClinicalTrials.gov) | April 1, 2020 | 31/3/2020 | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Diet in Ulcerative Colitis Patients | Dietary Supplement: Diet | Assiut University | NULL | Not yet recruiting | N/A | N/A | All | 50 | NULL | |
| 100 | EUCTR2019-003849-15-AT (EUCTR) | 20/03/2020 | 06/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany;Serbia;Belarus;United States | ||
| 101 | EUCTR2019-000733-39-DE (EUCTR) | 20/03/2020 | 13/03/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 102 | EUCTR2018-001605-93-AT (EUCTR) | 09/03/2020 | 07/11/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 103 | NCT04277546 (ClinicalTrials.gov) | March 3, 2020 | 18/2/2020 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) | Ulcerative Colitis | Drug: Brazikumab Maintenance Dose;Drug: Brazikumab Induction Dose | AstraZeneca | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 165 | Phase 2 | United States;Austria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Bulgaria;Romania |
| 104 | EUCTR2018-003986-33-DK (EUCTR) | 28/02/2020 | 02/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 105 | EUCTR2019-003113-34-HU (EUCTR) | 25/02/2020 | 09/01/2020 | Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany | ||
| 106 | EUCTR2018-003986-33-GB (EUCTR) | 24/02/2020 | 17/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 107 | EUCTR2019-003113-34-DE (EUCTR) | 19/02/2020 | 08/11/2019 | Ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Germany;Norway;Czech Republic;Hungary;United States | ||
| 108 | EUCTR2018-003986-33-ES (EUCTR) | 14/02/2020 | 24/02/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany | ||
| 109 | EUCTR2019-000733-39-AT (EUCTR) | 13/02/2020 | 14/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belgium;Poland;Germany;Serbia;Belarus;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada | ||
| 110 | EUCTR2018-003986-33-BG (EUCTR) | 11/02/2020 | 23/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 111 | NCT04074590 (ClinicalTrials.gov) | February 3, 2020 | 29/8/2019 | Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis | A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: LYS006;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Bulgaria;Czechia;Germany;Hungary;Norway;Poland;Russian Federation;Slovakia;United Kingdom |
| 112 | EUCTR2018-004491-35-RO (EUCTR) | 30/01/2020 | 18/03/2022 | A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE | Incyte Corporation | NULL | Not Recruiting | Female: yes Male: yes | 206 | Phase 2 | United States;Czechia;Poland;Romania;Germany | ||
| 113 | EUCTR2018-003986-33-LV (EUCTR) | 24/01/2020 | 01/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 114 | EUCTR2018-003985-15-AT (EUCTR) | 21/01/2020 | 08/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 115 | EUCTR2018-003985-15-FR (EUCTR) | 20/01/2020 | 12/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 116 | EUCTR2018-003986-33-FR (EUCTR) | 14/01/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 117 | NCT04023396 (ClinicalTrials.gov) | January 13, 2020 | 5/7/2019 | Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 217 | Phase 2 | Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom |
| 118 | EUCTR2019-000733-39-IT (EUCTR) | 08/01/2020 | 22/01/2021 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. - na | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABX464 Product Code: [ABX464] INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands | ||
| 119 | EUCTR2018-003986-33-LT (EUCTR) | 31/12/2019 | 08/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 120 | EUCTR2018-003278-28-NL (EUCTR) | 13/12/2019 | 22/07/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 121 | EUCTR2019-000733-39-ES (EUCTR) | 11/12/2019 | 11/11/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany | ||
| 122 | NCT04133194 (ClinicalTrials.gov) | November 28, 2019 | 10/10/2019 | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial) | Ulcerative Colitis | Drug: Mesalazine | Flemming Bendtsen | NULL | Recruiting | 18 Years | 60 Years | All | 200 | Phase 4 | Denmark |
| 123 | EUCTR2019-000733-39-SK (EUCTR) | 21/11/2019 | 06/09/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 124 | EUCTR2018-001605-93-CZ (EUCTR) | 21/11/2019 | 05/08/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 125 | EUCTR2019-000733-39-SI (EUCTR) | 11/11/2019 | 16/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 126 | EUCTR2019-000733-39-PL (EUCTR) | 09/11/2019 | 12/09/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 127 | EUCTR2018-003986-33-HR (EUCTR) | 08/11/2019 | 17/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 128 | EUCTR2018-003986-33-HU (EUCTR) | 07/11/2019 | 08/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 129 | EUCTR2018-002135-19-BG (EUCTR) | 30/10/2019 | 11/07/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Japan;Germany;Bulgaria;Georgia;Romania;Croatia;Poland;Canada;Hungary;United Kingdom;Korea, Republic of;South Africa;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Portugal;Serbia;United States | ||
| 130 | EUCTR2018-003278-28-HU (EUCTR) | 24/10/2019 | 25/03/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 131 | EUCTR2018-003986-33-IT (EUCTR) | 23/10/2019 | 22/01/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Other descriptive name: APD334 L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 132 | EUCTR2018-003985-15-ES (EUCTR) | 21/10/2019 | 21/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 133 | EUCTR2018-003985-15-PT (EUCTR) | 14/10/2019 | 10/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Belarus;Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 134 | EUCTR2018-003986-33-BE (EUCTR) | 14/10/2019 | 15/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany | ||
| 135 | EUCTR2018-001605-93-RO (EUCTR) | 10/10/2019 | 15/03/2022 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 136 | EUCTR2018-001605-93-BG (EUCTR) | 09/10/2019 | 20/09/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 137 | EUCTR2018-003986-33-NL (EUCTR) | 03/10/2019 | 22/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 138 | EUCTR2018-003985-15-IT (EUCTR) | 02/10/2019 | 22/01/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Other descriptive name: APD334 L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 139 | EUCTR2018-003985-15-BG (EUCTR) | 27/09/2019 | 12/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Serbia;Belarus;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 140 | EUCTR2018-003985-15-DK (EUCTR) | 27/09/2019 | 24/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 141 | EUCTR2018-001605-93-IT (EUCTR) | 26/09/2019 | 29/01/2021 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFU | ALLERGAN LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 142 | EUCTR2018-003985-15-CZ (EUCTR) | 26/09/2019 | 31/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 143 | EUCTR2018-003278-28-CZ (EUCTR) | 25/09/2019 | 15/04/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Czechia;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 144 | EUCTR2018-001605-93-BE (EUCTR) | 23/09/2019 | 07/06/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 145 | EUCTR2017-004496-31-NL (EUCTR) | 20/09/2019 | 27/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 146 | NCT03847467 (ClinicalTrials.gov) | September 20, 2019 | 12/2/2019 | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Drug: 2'-Fucosyllactose;Other: Placebo | Children's Hospital Medical Center, Cincinnati | Broad Institute;University of Cincinnati;Connecticut Children's Medical Center | Recruiting | 11 Years | 25 Years | All | 216 | Phase 1/Phase 2 | United States |
| 147 | EUCTR2018-003985-15-NL (EUCTR) | 18/09/2019 | 09/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 148 | EUCTR2018-002135-19-GR (EUCTR) | 13/09/2019 | 04/06/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 149 | EUCTR2018-001605-93-FR (EUCTR) | 13/09/2019 | 25/06/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 150 | EUCTR2018-002136-24-FR (EUCTR) | 10/09/2019 | 19/12/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 151 | EUCTR2019-002070-31-DK (EUCTR) | 05/09/2019 | 24/06/2019 | Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial) | Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) | Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Asacol® INN or Proposed INN: MESALAZINE | Copenhagen University Hospital Hvidovre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | Denmark | ||
| 152 | EUCTR2018-003985-15-LT (EUCTR) | 27/08/2019 | 10/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 153 | EUCTR2018-002135-19-DE (EUCTR) | 26/08/2019 | 25/02/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 154 | EUCTR2018-003985-15-EE (EUCTR) | 26/08/2019 | 15/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 155 | EUCTR2018-004491-35-PL (EUCTR) | 19/08/2019 | 03/07/2019 | A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 206 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Romania;Germany | ||
| 156 | EUCTR2018-003985-15-HR (EUCTR) | 14/08/2019 | 24/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey | ||
| 157 | NCT03869905 (ClinicalTrials.gov) | August 8, 2019 | 8/3/2019 | Aquamin® as an Adjuvant Intervention for Ulcerative Colitis | Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission | Ulcerative Colitis | Drug: Aquamin®;Drug: Placebo first then Aquamin® | James Varani | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | United States |
| 158 | EUCTR2018-001605-93-ES (EUCTR) | 07/08/2019 | 09/08/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 159 | EUCTR2018-003278-28-PL (EUCTR) | 03/08/2019 | 11/06/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of | ||
| 160 | EUCTR2016-004676-22-BG (EUCTR) | 30/07/2019 | 14/05/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 161 | EUCTR2018-003985-15-HU (EUCTR) | 29/07/2019 | 16/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 162 | EUCTR2018-003985-15-LV (EUCTR) | 05/07/2019 | 02/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 163 | EUCTR2018-001605-93-GB (EUCTR) | 01/07/2019 | 04/04/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 164 | EUCTR2018-003986-33-SK (EUCTR) | 01/07/2019 | 02/05/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 165 | EUCTR2018-002136-24-DE (EUCTR) | 25/06/2019 | 27/12/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 166 | NCT03923478 (ClinicalTrials.gov) | June 24, 2019 | 15/4/2019 | ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Drug: ABI-M201;Drug: Placebo | Assembly Biosciences | NULL | Terminated | 18 Years | 70 Years | All | 15 | Phase 1 | United States;Canada |
| 167 | EUCTR2018-003985-15-SK (EUCTR) | 21/06/2019 | 16/04/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Chile;Russian Federation;Lebanon;Ukraine;Spain;Thailand;Slovakia;Estonia;Taiwan;Belarus;Portugal;Serbia;United States | ||
| 168 | EUCTR2018-002135-19-PL (EUCTR) | 19/06/2019 | 05/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 169 | NCT03945188 (ClinicalTrials.gov) | June 13, 2019 | 8/5/2019 | Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 16 Years | 80 Years | All | 433 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Colombia;Switzerland |
| 170 | EUCTR2018-002136-24-BG (EUCTR) | 12/06/2019 | 18/01/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 171 | EUCTR2018-002135-19-ES (EUCTR) | 10/06/2019 | 12/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 172 | EUCTR2018-002135-19-PT (EUCTR) | 05/06/2019 | 15/03/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan | ||
| 173 | EUCTR2018-002135-19-SK (EUCTR) | 28/05/2019 | 15/03/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 174 | EUCTR2018-002136-24-ES (EUCTR) | 23/05/2019 | 11/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 175 | EUCTR2016-004676-22-SI (EUCTR) | 20/05/2019 | 06/02/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Bulgaria;Romania;Croatia;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Denmark;Australia;Malaysia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Belarus;Portugal;Serbia;United States;Sweden;Japan;New Zealand;Germany;Brazil;Belgium | ||
| 176 | EUCTR2018-003278-28-FR (EUCTR) | 07/05/2019 | 09/05/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 177 | EUCTR2018-003278-28-GB (EUCTR) | 29/04/2019 | 14/12/2018 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 178 | EUCTR2018-002135-19-HU (EUCTR) | 11/04/2019 | 19/02/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 179 | EUCTR2018-002136-24-PL (EUCTR) | 04/04/2019 | 18/01/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 180 | EUCTR2018-002136-24-GR (EUCTR) | 03/04/2019 | 18/02/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 181 | NCT04224857 (ClinicalTrials.gov) | April 1, 2019 | 23/5/2019 | SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101 | Ulcerative Colitis | Drug: AMT-101;Drug: Placebos | Applied Molecular Transport | NULL | Completed | 18 Years | N/A | All | 52 | Phase 1 | Georgia;Germany;Moldova, Republic of;Ukraine |
| 182 | NCT03794765 (ClinicalTrials.gov) | April 1, 2019 | 4/1/2019 | Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis | Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial | Ulcerative Colitis;Inflammatory Bowel Diseases;Acute Severe Colitis | Drug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusion | Postgraduate Institute of Medical Education and Research | NULL | Completed | 13 Years | N/A | All | 50 | Phase 2 | India |
| 183 | EUCTR2018-002136-24-PT (EUCTR) | 18/03/2019 | 02/01/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 184 | NCT03773445 (ClinicalTrials.gov) | March 1, 2019 | 25/11/2018 | Golimumab Trough Levels in Patients With Ulcerative Colitis | Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis | Ulcerative Colitis | Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy | Hospital San Carlos, Madrid | Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 100 | Spain | |
| 185 | NCT04700449 (ClinicalTrials.gov) | February 27, 2019 | 22/10/2020 | A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) | Moderate to Severe Ulcerative Colitis | Drug: CBP-307;Drug: Placebo | Suzhou Connect Biopharmaceuticals, Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 134 | Phase 2 | United States;China;Pakistan;Ukraine |
| 186 | NCT03942861 (ClinicalTrials.gov) | February 21, 2019 | 25/4/2019 | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Ulcerative Colitis;Ultrasound Therapy; Complications | Drug: Solu-Medrol | Copenhagen University Hospital at Herlev | NULL | Recruiting | 18 Years | 70 Years | All | 50 | Denmark | |
| 187 | EUCTR2018-002136-24-SK (EUCTR) | 19/02/2019 | 28/12/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 188 | EUCTR2018-002136-24-HU (EUCTR) | 18/02/2019 | 29/03/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 189 | EUCTR2017-004496-31-IT (EUCTR) | 18/02/2019 | 17/06/2021 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: SIMPONI Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: [CNTO312] INN or Proposed INN: INFLIXIMAB Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 190 | JPRN-JapicCTI-194603 | 01/2/2019 | 30/01/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis] | Ulcerative colitis | Intervention name : Vedolizumab INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab intravenous (IV) infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | recruiting | BOTH | 1000 | NA | Japan | ||
| 191 | EUCTR2016-004676-22-HR (EUCTR) | 01/02/2019 | 16/05/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Lithuania;Slovenia;Korea, Republic of;China;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Belarus;United States;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 192 | EUCTR2017-004496-31-PL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Belgium;Brazil;Poland;Israel;Netherlands;Italy;Korea, Republic of | ||
| 193 | EUCTR2016-004676-22-DE (EUCTR) | 22/01/2019 | 15/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 194 | NCT03804931 (ClinicalTrials.gov) | January 20, 2019 | 6/1/2019 | Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Procedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone | Guangzhou First People's Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 120 | Phase 2/Phase 3 | China |
| 195 | NCT04114292 (ClinicalTrials.gov) | January 17, 2019 | 25/9/2019 | TUDCA as a Therapy for Ulcerative Colitis (UC) | A Phase I Open Label Study of the Efficacy and Safety of Tudca in Ulcerative Colitis | Ulcerative Colitis | Drug: Tauroursoursodeoxycholic acid, brand name Tudcabil | Washington University School of Medicine | Crohn's and Colitis Foundation | Recruiting | 18 Years | 65 Years | All | 13 | Phase 1 | United States |
| 196 | EUCTR2016-004676-22-BE (EUCTR) | 14/01/2019 | 04/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 197 | EUCTR2018-000930-37-NL (EUCTR) | 21/12/2018 | 11/10/2018 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Product Code: ABBV-323 INN or Proposed INN: Not assigned Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Hungary;Canada;Spain;Germany;Netherlands;United Kingdom;Italy;Korea, Republic of | ||
| 198 | EUCTR2016-004676-22-GB (EUCTR) | 20/12/2018 | 03/07/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 199 | NCT03759041 (ClinicalTrials.gov) | December 19, 2018 | 27/11/2018 | A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis | ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Vancomycin Pre-Treatment;Drug: Placebo for Vancomycin Pre-Treatment;Drug: SER-287;Drug: Placebo for SER-287 | Seres Therapeutics, Inc. | NULL | Terminated | 18 Years | 80 Years | All | 203 | Phase 2 | United States;Canada |
| 200 | JPRN-JapicCTI-184131 | 18/12/2018 | 28/09/2018 | A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675] | Ulcerative Colitis | Intervention name : ABT-494 INN of the intervention : upadacitinib Dosage And administration of the intervention : Will be orally administered Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Will be orally administered | AbbVie GK | NULL | complete | 16 | 75 | BOTH | 45 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa, - |
| 201 | EUCTR2017-004496-31-FR (EUCTR) | 17/12/2018 | 14/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 202 | ChiCTR1800019676 | 2018-12-01 | 2018-11-22 | Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis | Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis: a single center, prospective cohort study | ulcerative colitis | Gold Standard:Histopathological examination;Index test:1, Gland density (grade) 2. Gland morphology (grade) 3. Vascular changes (grade); | Peking University First Hospital | NULL | Pending | 18 | 80 | Both | Target condition:40;Difficult condition:0 | China | |
| 203 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 204 | NCT02201758 (ClinicalTrials.gov) | December 2018 | 18/7/2014 | Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment | Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment. | Ulcerative Colitis | Dietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: Placebo | University of Saskatchewan | Royal University Hospital Foundation | Unknown status | 18 Years | N/A | All | 56 | Phase 2 | Canada |
| 205 | EUCTR2017-004496-31-BE (EUCTR) | 07/11/2018 | 25/07/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Brazil;Belgium;Israel;Netherlands;Italy;Korea, Republic of | ||
| 206 | NCT03596645 (ClinicalTrials.gov) | October 29, 2018 | 13/7/2018 | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Drug: Infliximab | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan |
| 207 | EUCTR2016-004676-22-GR (EUCTR) | 26/10/2018 | 04/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Bulgaria;Germany;Japan;New Zealand;Sweden;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey | ||
| 208 | EUCTR2017-004496-31-ES (EUCTR) | 15/10/2018 | 28/08/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 209 | EUCTR2016-004676-22-SE (EUCTR) | 02/10/2018 | 16/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 210 | NCT03483246 (ClinicalTrials.gov) | September 17, 2018 | 26/2/2018 | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial | Ulcerative Colitis | Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation Placebo | Assistance Publique - Hôpitaux de Paris | CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France | Recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | France |
| 211 | EUCTR2018-001051-12-FR (EUCTR) | 07/09/2018 | 19/04/2018 | VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis | VEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: ENTYVIO Product Code: 1 | CHU Saint-Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 4 | France | ||
| 212 | EUCTR2016-004676-22-LV (EUCTR) | 30/08/2018 | 29/08/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 213 | NCT03398135 (ClinicalTrials.gov) | August 28, 2018 | 8/1/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: risankizumab;Drug: placebo for risankizumab | AbbVie | NULL | Enrolling by invitation | 16 Years | 80 Years | All | 942 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Hungary |
| 214 | JPRN-JapicCTI-184008 | 28/8/2018 | 21/06/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066] | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066] | Ulcerative Colitis (UC) | Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | AbbVie GK | NULL | recruiting | 16 | 80 | BOTH | 70 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa |
| 215 | EUCTR2017-000573-37-EE (EUCTR) | 27/08/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United States;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 216 | EUCTR2016-004676-22-LT (EUCTR) | 23/08/2018 | 26/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 217 | EUCTR2016-004676-22-SK (EUCTR) | 14/08/2018 | 05/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 218 | NCT03546868 (ClinicalTrials.gov) | August 14, 2018 | 10/5/2018 | Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease | Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease. | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Drug: [18F]FSPG | Asan Foundation | NULL | Completed | 19 Years | 79 Years | All | 20 | Phase 2 | Korea, Republic of |
| 219 | NCT03616821 (ClinicalTrials.gov) | August 7, 2018 | 1/8/2018 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) | Ulcerative Colitis;IBD | Drug: Brazikumab;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 80 Years | All | 256 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 220 | NCT04718818 (ClinicalTrials.gov) | August 7, 2018 | 19/1/2021 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Brazikumab;Drug: Vedolizumab;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 80 Years | All | 225 | Phase 2 | United States;Canada;India;Korea, Republic of;Puerto Rico;Romania;Taiwan |
| 221 | JPRN-JapicCTI-184062 | 02/8/2018 | 10/08/2018 | I6T-MC-AMAP | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Mirikizumab administered subcutaneously (SC) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Eli Lilly Japan K.K. | NULL | complete | 18 | 80 | BOTH | 142 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Middle East |
| 222 | EUCTR2017-002108-28-DE (EUCTR) | 25/07/2018 | 27/03/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of | ||
| 223 | EUCTR2015-001600-64-AT (EUCTR) | 25/07/2018 | 17/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 224 | EUCTR2015-000319-41-GR (EUCTR) | 23/07/2018 | 18/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 225 | EUCTR2015-001600-64-GR (EUCTR) | 23/07/2018 | 19/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 226 | EUCTR2016-004676-22-PT (EUCTR) | 16/07/2018 | 02/07/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 227 | EUCTR2015-001600-64-ES (EUCTR) | 12/07/2018 | 21/05/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 228 | EUCTR2015-000319-41-ES (EUCTR) | 12/07/2018 | 21/05/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 229 | NCT03609905 (ClinicalTrials.gov) | July 1, 2018 | 1/6/2018 | Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis | A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients | Ulcerative Colitis (UC) | Biological: Adipose-cord mesenchymal stromal cells (A-MSCs);Other: Conventional drugs | Liaocheng People's Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 1/Phase 2 | China |
| 230 | EUCTR2016-004676-22-AT (EUCTR) | 25/06/2018 | 06/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Czechia;Slovenia;Lithuania;Turkey;Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 231 | EUCTR2015-000319-41-LV (EUCTR) | 22/06/2018 | 13/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 232 | EUCTR2015-001600-64-LV (EUCTR) | 22/06/2018 | 13/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;Latvia;South Africa;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Germany;New Zealand | ||
| 233 | EUCTR2017-000572-28-BE (EUCTR) | 08/06/2018 | 14/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 234 | JPRN-JapicCTI-183997 | 29/5/2018 | 12/06/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067] | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067] | Ulcerative Colitis (UC) | Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | AbbVie GK | NULL | recruiting | 16 | 80 | BOTH | 65 | Phase 2-3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa |
| 235 | EUCTR2015-000319-41-AT (EUCTR) | 25/05/2018 | 17/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 236 | EUCTR2017-002108-28-IT (EUCTR) | 15/05/2018 | 22/01/2021 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: [PF-06687234] INN or Proposed INN: PF-06687234 | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Serbia;Saudi Arabia;Spain;Belgium;Korea, Democratic People's Republic of;Australia;Israel;Germany;Italy | ||
| 237 | EUCTR2017-000573-37-HR (EUCTR) | 23/04/2018 | 07/12/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Serbia;Portugal;Estonia;Slovakia;Greece | ||
| 238 | EUCTR2017-000599-27-HR (EUCTR) | 20/04/2018 | 07/12/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 239 | EUCTR2016-003708-29-BG (EUCTR) | 20/04/2018 | 17/01/2018 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 240 | EUCTR2017-000599-27-IT (EUCTR) | 19/04/2018 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,compared with placebo (dummy treatment) ¿ using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects withModerate to Severe Ulcerative Colitis (FIGARO UC 301) - FIGARO UC 301 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: - Product Code: [SHP647] INN or Proposed INN: ontamalimab Product Name: - Product Code: [SHP647] INN or Proposed INN: ontamalimab | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Czechia;Slovenia;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 241 | EUCTR2017-000573-37-IT (EUCTR) | 19/04/2018 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,compared with placebo (dummy treatment) ¿ using a randomised andblinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel groupEfficacy and Safety Study of SHP647 as Maintenance Therapy in SubjectsWith Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: [SHP647] INN or Proposed INN: ontamalimab Product Code: [SHP647] INN or Proposed INN: ontamalimab | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 242 | EUCTR2017-002108-28-ES (EUCTR) | 12/04/2018 | 20/04/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: Dekavil Other descriptive name: F8IL10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of | ||
| 243 | EUCTR2017-000599-27-DE (EUCTR) | 10/04/2018 | 24/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 244 | EUCTR2017-000573-37-DE (EUCTR) | 10/04/2018 | 24/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 245 | NCT03290781 (ClinicalTrials.gov) | April 4, 2018 | 6/9/2017 | An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) | Ulcerative Colitis | Drug: Ontamalimab;Other: Placebo | Shire | NULL | Completed | 16 Years | 81 Years | All | 366 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;France |
| 246 | EUCTR2017-002108-28-BE (EUCTR) | 30/03/2018 | 22/03/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of | ||
| 247 | NCT03482648 (ClinicalTrials.gov) | March 20, 2018 | 17/3/2018 | First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers | A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects | Ulcerative Colitis | Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Completed | 19 Years | 55 Years | All | 80 | Phase 1 | United States |
| 248 | NCT04969679 (ClinicalTrials.gov) | March 16, 2018 | 7/7/2021 | Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment. | A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment. | Ulcerative Colitis | Drug: E. coli Nissle 1917 (Mutaflor®);Drug: Placebo | Kangbuk Samsung Hospital | NULL | Completed | 19 Years | N/A | All | 134 | Phase 4 | Korea, Republic of |
| 249 | EUCTR2017-000573-37-NL (EUCTR) | 15/03/2018 | 02/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 250 | EUCTR2017-000599-27-NL (EUCTR) | 15/03/2018 | 02/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 251 | EUCTR2017-000573-37-IE (EUCTR) | 13/03/2018 | 04/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 252 | EUCTR2017-000572-28-PT (EUCTR) | 13/03/2018 | 22/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 253 | EUCTR2017-000573-37-PT (EUCTR) | 13/03/2018 | 21/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 772 | Phase 3 | Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Turkey;Lithuania;Czechia;Bosnia and Herzegovina;Korea, Republic of;Netherlands;South Africa;Australia;France;Italy;Switzerland;Colombia;Israel;Russian Federation;Lebanon;Ireland;Ukraine;Spain;Greece;Slovakia;Estonia;United States;Serbia;Portugal | ||
| 254 | EUCTR2017-000573-37-GB (EUCTR) | 07/03/2018 | 25/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 772 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 255 | EUCTR2017-000599-27-GB (EUCTR) | 07/03/2018 | 05/12/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan | ||
| 256 | EUCTR2017-000573-37-CZ (EUCTR) | 27/02/2018 | 01/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 257 | EUCTR2017-000599-27-CZ (EUCTR) | 26/02/2018 | 01/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 258 | EUCTR2017-000573-37-ES (EUCTR) | 16/02/2018 | 19/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 259 | EUCTR2017-000572-28-FR (EUCTR) | 16/02/2018 | 16/02/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 260 | EUCTR2017-000572-28-ES (EUCTR) | 16/02/2018 | 19/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 261 | NCT03259334 (ClinicalTrials.gov) | February 9, 2018 | 21/8/2017 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative Colitis | Drug: Ontamalimab;Other: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 380 | Phase 3 | United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom |
| 262 | EUCTR2017-000599-27-LT (EUCTR) | 30/01/2018 | 31/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Czechia;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 263 | EUCTR2017-000573-37-LT (EUCTR) | 30/01/2018 | 31/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 264 | EUCTR2017-000573-37-BG (EUCTR) | 24/01/2018 | 22/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 265 | EUCTR2017-000572-28-HU (EUCTR) | 22/01/2018 | 27/10/2017 | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 266 | EUCTR2017-000573-37-HU (EUCTR) | 22/01/2018 | 23/01/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 267 | EUCTR2017-000572-28-BG (EUCTR) | 19/01/2018 | 24/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 268 | EUCTR2017-000573-37-AT (EUCTR) | 22/12/2017 | 30/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 269 | EUCTR2017-000599-27-AT (EUCTR) | 22/12/2017 | 30/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 270 | NCT03269695 (ClinicalTrials.gov) | December 20, 2017 | 30/8/2017 | Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) | Ulcerative Colitis | Drug: PF-06687234;Drug: Placebo | Pfizer | NULL | Terminated | 18 Years | 75 Years | All | 20 | Phase 2 | United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain |
| 271 | EUCTR2014-001594-14-DE (EUCTR) | 19/12/2017 | 22/09/2014 | Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site | Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: FITC-Adalimumab Product Code: FITC-Adalimumab INN or Proposed INN: FITC-Adalimumab Other descriptive name: FITC-ADALIMUMAB | Universitätsklinikum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 1;Phase 2 | Germany | ||
| 272 | JPRN-UMIN000032250 | 2017/12/15 | 14/04/2018 | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia - Dual center study of pCLE for UCAN | suspected ulcerative colitis-associated neoplasia | pCLE after intravenous administration of fluorescein | Fujita Health University School of Medicine, Department of Gastroenterology | Center for Diagnostic and Therapeutic Endoscopy, School of Medicine KeioUniversity | Recruiting | 20years-old | 85years-old | Male and Female | 40 | Not applicable | Japan |
| 273 | JPRN-jRCTs041180035 | 15/12/2017 | 31/01/2019 | Dual center study of pCLE for UCAN | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia | suspected ulcerative colitis-associated neoplasia | pCLE after intravenous administration of fluorescein | Ohmiya Naoki | NULL | Recruiting | >= 20age old | < 80age old | Both | 30 | N/A | Japan |
| 274 | EUCTR2017-000572-28-SK (EUCTR) | 13/12/2017 | 21/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina | ||
| 275 | EUCTR2017-000573-37-GR (EUCTR) | 11/12/2017 | 01/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 276 | EUCTR2017-000572-28-GR (EUCTR) | 11/12/2017 | 28/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 277 | EUCTR2017-000573-37-SK (EUCTR) | 08/12/2017 | 21/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 278 | NCT03259308 (ClinicalTrials.gov) | December 5, 2017 | 21/8/2017 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis | Drug: Ontamalimab;Drug: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 279 | Phase 3 | United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Turkey;Ukraine;France |
| 279 | NCT02559713 (ClinicalTrials.gov) | November 29, 2017 | 23/9/2015 | Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease | An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | N/A | Female | 11 | Phase 4 | United States |
| 280 | EUCTR2015-005753-12-GB (EUCTR) | 22/11/2017 | 02/08/2018 | A research study looking at faecal transplant as a treatment for ulcerative colitis, and the best way to use it in children and adults with the condition | Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis. - STOP-Colitis Pilot Trial | Ulcerative colitis for at least 3 months prior to trial entry;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Faecal Microbiota Transplant Product Code: FMT INN or Proposed INN: faecal matter | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | United Kingdom | ||
| 281 | EUCTR2016-000420-26-BG (EUCTR) | 17/11/2017 | 19/04/2017 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy | ||
| 282 | EUCTR2016-003708-29-NL (EUCTR) | 09/11/2017 | 19/07/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | Serbia;Slovakia;Spain;Ukraine;Ireland;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of;United States | ||
| 283 | EUCTR2016-001392-78-NL (EUCTR) | 06/11/2017 | 16/08/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 284 | EUCTR2016-003708-29-IT (EUCTR) | 01/09/2017 | 22/01/2021 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 10 mg Product Code: [PF-06651600 10 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06651600 50 mg Product Code: [PF-06651600 50 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg Product Code: [PF-06700841 5 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg Product Code: [PF-06700841 25 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 285 | EUCTR2016-003708-29-AT (EUCTR) | 07/08/2017 | 24/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 286 | EUCTR2016-003708-29-DE (EUCTR) | 07/08/2017 | 24/04/2017 | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 287 | EUCTR2017-000100-20-GB (EUCTR) | 17/07/2017 | 14/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;United Kingdom | ||
| 288 | EUCTR2016-003708-29-HU (EUCTR) | 30/06/2017 | 11/05/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 289 | EUCTR2016-003708-29-DK (EUCTR) | 27/06/2017 | 21/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 290 | EUCTR2016-001392-78-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Georgia;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Singapore;Belgium | ||
| 291 | JPRN-UMIN000026175 | 2017/06/23 | 01/03/2017 | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis | Ulcerative colitis | Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa . PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part . | Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University | NULL | Complete: follow-up complete | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan |
| 292 | EUCTR2016-003708-29-PL (EUCTR) | 07/06/2017 | 26/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 293 | EUCTR2017-000100-20-DE (EUCTR) | 06/06/2017 | 09/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;United Kingdom | ||
| 294 | EUCTR2016-003708-29-LT (EUCTR) | 06/06/2017 | 18/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 295 | EUCTR2016-001392-78-NO (EUCTR) | 31/05/2017 | 13/05/2019 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Italy;United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Iceland;New Zealand;Japan;Sweden | ||
| 296 | EUCTR2016-001392-78-SE (EUCTR) | 24/05/2017 | 12/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 297 | NCT03100864 (ClinicalTrials.gov) | May 22, 2017 | 31/3/2017 | This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC) | Colitis, Ulcerative | Drug: Spesolimab | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 8 | Phase 2 | Belgium;Germany;United Kingdom |
| 298 | EUCTR2016-003708-29-ES (EUCTR) | 22/05/2017 | 31/05/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | Serbia;United States;Philippines;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of | ||
| 299 | EUCTR2017-000100-20-BE (EUCTR) | 08/05/2017 | 17/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Belgium;Germany;United Kingdom | ||
| 300 | NCT03103412 (ClinicalTrials.gov) | May 4, 2017 | 24/3/2017 | TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects | Drug: TD-3504;Drug: 15N2-tofacitinib;Drug: Placebo | Theravance Biopharma | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | United States |
| 301 | EUCTR2016-001392-78-IS (EUCTR) | 24/04/2017 | 21/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Czech Republic;Hungary;Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 302 | EUCTR2016-003708-29-SK (EUCTR) | 18/04/2017 | 24/02/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 303 | EUCTR2016-001392-78-BG (EUCTR) | 04/04/2017 | 07/02/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 304 | EUCTR2016-001392-78-GR (EUCTR) | 31/03/2017 | 14/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 305 | EUCTR2016-001392-78-BE (EUCTR) | 31/03/2017 | 09/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 306 | EUCTR2016-001392-78-DE (EUCTR) | 27/03/2017 | 05/04/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 307 | EUCTR2016-003633-26-PL (EUCTR) | 23/03/2017 | 27/12/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 308 | EUCTR2015-002557-35-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 309 | EUCTR2015-002558-11-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 310 | EUCTR2016-001392-78-PT (EUCTR) | 13/03/2017 | 13/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 311 | EUCTR2016-003633-26-CZ (EUCTR) | 10/03/2017 | 12/12/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 312 | EUCTR2016-001392-78-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 313 | NCT03071081 (ClinicalTrials.gov) | February 8, 2017 | 20/2/2017 | Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy Volunteers | Ulcerative Colitis | Drug: TOP1288;Drug: Placebo to TOP1288 | Topivert Pharma Ltd | NULL | Completed | 18 Years | 55 Years | Male | 37 | Phase 1 | United Kingdom |
| 314 | NCT02958865 (ClinicalTrials.gov) | February 3, 2017 | 4/11/2016 | Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-06651600 or Placebo;Drug: PF-06700841 or Placebo;Drug: PF-06700841;Drug: PF-06651600 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 319 | Phase 2 | United States;Austria;Bulgaria;Czechia;Denmark;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Turkey;Ukraine;Canada;Netherlands |
| 315 | JPRN-jRCTs031180415 | 01/02/2017 | 22/03/2019 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) | AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults). FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. A-FMT arm : Patient undergoes FMT two days after AFM therapy. | Ishikawa Dai | NULL | Recruiting | >= 6age old | Not applicable | Both | 120 | N/A | Japan |
| 316 | NCT03038711 (ClinicalTrials.gov) | February 1, 2017 | 26/1/2017 | A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers | A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects | Ulcerative Colitis | Drug: BMS-986166;Other: Placebo matching BMS-986166 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 213 | Phase 1 | United States |
| 317 | EUCTR2016-001392-78-AT (EUCTR) | 31/01/2017 | 13/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 318 | EUCTR2016-001392-78-ES (EUCTR) | 31/01/2017 | 01/02/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 319 | EUCTR2016-000420-26-PL (EUCTR) | 31/01/2017 | 01/02/2017 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Czech Republic;Spain;Poland;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom | ||
| 320 | EUCTR2016-001392-78-HU (EUCTR) | 30/01/2017 | 01/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 321 | EUCTR2015-001600-64-HR (EUCTR) | 19/01/2017 | 05/06/2017 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 322 | EUCTR2015-000319-41-HR (EUCTR) | 17/01/2017 | 05/06/2017 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 323 | EUCTR2016-003633-26-NL (EUCTR) | 17/01/2017 | 24/10/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 324 | EUCTR2016-003633-26-HU (EUCTR) | 23/12/2016 | 08/11/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands | ||
| 325 | EUCTR2016-001392-78-GB (EUCTR) | 08/12/2016 | 06/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 326 | EUCTR2016-000518-31-CZ (EUCTR) | 07/11/2016 | 30/08/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 327 | NCT02764229 (ClinicalTrials.gov) | November 1, 2016 | 4/5/2016 | Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis | A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: LYC-30937-EC | Lycera Corp. | NULL | Terminated | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Czechia;Hungary;Netherlands;Poland;Serbia |
| 328 | EUCTR2016-000509-35-BG (EUCTR) | 27/10/2016 | 03/08/2016 | Drug OPRX-106 in Patients with Ulcerative Colitis | An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative Colitis | Active mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg Product Code: OPRX-106 Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg Product Code: OPRX-106 | Protalix Biotherapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Serbia;Israel;Bulgaria | ||
| 329 | EUCTR2016-000518-31-PL (EUCTR) | 21/10/2016 | 19/08/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 330 | EUCTR2015-001600-64-BG (EUCTR) | 13/10/2016 | 01/10/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 331 | EUCTR2016-000420-26-CZ (EUCTR) | 06/10/2016 | 27/07/2016 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom | ||
| 332 | EUCTR2016-000518-31-HU (EUCTR) | 05/10/2016 | 27/07/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands | ||
| 333 | EUCTR2016-000420-26-ES (EUCTR) | 05/10/2016 | 05/08/2016 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Poland;Spain;Romania;France;Czech Republic;Bulgaria;South Africa;Georgia;United Kingdom;Moldova, Republic of;Italy | ||
| 334 | NCT02864264 (ClinicalTrials.gov) | September 14, 2016 | 9/8/2016 | Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis | Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis | Healthy Volunteers;Ulcerative Colitis | Drug: BMS-986184;Drug: Placebo matching BMS-986184 | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 75 Years | All | 7 | Phase 1 | Australia;Georgia;Moldova, Republic of;Romania |
| 335 | JPRN-UMIN000022588 | 2016/09/01 | 01/07/2016 | Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection. | Ulcerative colitis | Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks) Additional immunosuppressive therapies without administration of ganciclovir | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 120 | Not applicable | Japan | |
| 336 | EUCTR2015-002558-11-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 337 | EUCTR2015-002557-35-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 338 | NCT02768974 (ClinicalTrials.gov) | September 2016 | 27/3/2016 | Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis | An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: OPRX-106 | Protalix | NULL | Recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | Israel |
| 339 | EUCTR2015-003123-57-PL (EUCTR) | 26/08/2016 | 16/05/2016 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 340 | EUCTR2016-000518-31-NL (EUCTR) | 16/08/2016 | 27/06/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 341 | EUCTR2016-000205-36-DE (EUCTR) | 11/07/2016 | 14/03/2016 | A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD). | A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE | Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: FE 999301 | University Hospital Schleswig-Holstein (UKSH) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany | |||
| 342 | NCT02762500 (ClinicalTrials.gov) | July 2016 | 3/5/2016 | An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: LYC-30937-EC;Drug: Placebo | Lycera Corp. | NULL | Completed | 18 Years | 75 Years | All | 124 | Phase 2 | United States;Canada;Czechia;Hungary;Netherlands;Poland;Serbia;Czech Republic |
| 343 | EUCTR2015-000480-14-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 344 | EUCTR2015-000482-31-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Bosnia and Herzegovina;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;United States;Serbia | ||
| 345 | EUCTR2014-005217-24-ES (EUCTR) | 29/06/2016 | 10/11/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis - NA | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 346 | EUCTR2015-000480-14-DE (EUCTR) | 14/06/2016 | 09/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 347 | EUCTR2015-000482-31-HR (EUCTR) | 13/06/2016 | 06/07/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 348 | NCT02665845 (ClinicalTrials.gov) | June 13, 2016 | 25/1/2016 | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis). | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial. | Ulcerative Colitis | Drug: 5-ASA;Drug: Corticosteroids | Centre Hospitalier Universitaire de Saint Etienne | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 349 | EUCTR2015-000480-14-HR (EUCTR) | 10/06/2016 | 06/07/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 350 | EUCTR2016-001278-13-FI (EUCTR) | 08/06/2016 | 15/04/2016 | Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis | Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD | Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | Taina Sipponen | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Finland | ||
| 351 | EUCTR2015-003123-57-DK (EUCTR) | 03/06/2016 | 22/03/2016 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 352 | EUCTR2015-003123-57-NL (EUCTR) | 02/06/2016 | 12/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 353 | NCT02647866 (ClinicalTrials.gov) | June 2016 | 8/12/2015 | Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UC | Ulcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal Pain | Drug: KHK4083;Drug: Placebo | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico |
| 354 | EUCTR2015-000482-31-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 355 | EUCTR2015-000480-14-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 356 | EUCTR2015-000482-31-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn?s Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 357 | EUCTR2015-000480-14-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 358 | EUCTR2015-000482-31-NL (EUCTR) | 25/05/2016 | 27/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: - Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 359 | EUCTR2014-005217-24-DE (EUCTR) | 24/05/2016 | 23/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 360 | EUCTR2014-005217-24-IS (EUCTR) | 10/05/2016 | 28/04/2016 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Germany;Iceland;New Zealand;Sweden | ||
| 361 | EUCTR2015-000480-14-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 362 | EUCTR2015-000482-31-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 363 | EUCTR2015-000482-31-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 364 | EUCTR2015-000480-14-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 365 | EUCTR2015-001600-64-NL (EUCTR) | 28/04/2016 | 13/10/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 366 | EUCTR2015-001555-69-PL (EUCTR) | 28/04/2016 | 22/12/2015 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation | ||
| 367 | EUCTR2015-000480-14-IT (EUCTR) | 18/04/2016 | 08/06/2021 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis. | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy. - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENTYVIO - 300 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 368 | EUCTR2015-000482-31-IT (EUCTR) | 18/04/2016 | 22/01/2021 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn¿s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 369 | EUCTR2015-000480-14-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 370 | EUCTR2015-000482-31-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 371 | NCT02749630 (ClinicalTrials.gov) | April 11, 2016 | 12/4/2016 | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD) | An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 70 | Phase 1 | Germany;United Kingdom;Canada |
| 372 | EUCTR2015-000482-31-SE (EUCTR) | 05/04/2016 | 16/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 373 | EUCTR2015-000480-14-SE (EUCTR) | 04/04/2016 | 16/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 374 | JPRN-UMIN000020029 | 2016/04/01 | 01/12/2015 | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation | Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies. | Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more. | Saitama Medical University | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 300 | Not selected | Japan |
| 375 | EUCTR2014-005217-24-HR (EUCTR) | 29/03/2016 | 28/04/2016 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 376 | EUCTR2015-003123-57-GB (EUCTR) | 29/03/2016 | 04/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 377 | EUCTR2015-000482-31-BG (EUCTR) | 23/03/2016 | 16/02/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 378 | EUCTR2015-000480-14-NL (EUCTR) | 21/03/2016 | 29/12/2015 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 379 | EUCTR2015-000482-31-GB (EUCTR) | 21/03/2016 | 08/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 380 | EUCTR2015-000480-14-BG (EUCTR) | 17/03/2016 | 16/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 381 | EUCTR2015-000480-14-GB (EUCTR) | 14/03/2016 | 07/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 382 | EUCTR2015-001555-69-CZ (EUCTR) | 07/03/2016 | 14/12/2015 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation | ||
| 383 | EUCTR2014-005217-24-SE (EUCTR) | 02/03/2016 | 03/11/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 384 | NCT02818543 (ClinicalTrials.gov) | March 2016 | 30/3/2016 | Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis | An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: LYC-30937 | Lycera Corp. | NULL | Completed | 18 Years | 75 Years | Both | 6 | Phase 1 | Hungary |
| 385 | EUCTR2015-002558-11-HU (EUCTR) | 09/02/2016 | 16/11/2015 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Serbia;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 386 | EUCTR2015-002557-35-HU (EUCTR) | 09/02/2016 | 16/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 387 | EUCTR2015-003123-57-BE (EUCTR) | 09/02/2016 | 01/10/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 388 | NCT02683759 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis | The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicyclic acid | Asian Institute of Gastroenterology, India | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 389 | NCT02683733 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis | The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicylic acid | Asian Institute of Gastroenterology, India | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 390 | EUCTR2015-000319-41-NL (EUCTR) | 26/01/2016 | 01/07/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 391 | EUCTR2015-000480-14-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 392 | EUCTR2015-000482-31-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 393 | EUCTR2015-001555-69-HU (EUCTR) | 15/01/2016 | 17/11/2015 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation | ||
| 394 | EUCTR2014-005217-24-BE (EUCTR) | 14/01/2016 | 26/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 395 | EUCTR2015-003123-57-CZ (EUCTR) | 14/01/2016 | 05/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 396 | EUCTR2014-005217-24-BG (EUCTR) | 05/01/2016 | 19/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 397 | EUCTR2015-003123-57-HU (EUCTR) | 05/01/2016 | 06/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 398 | EUCTR2015-001600-64-IT (EUCTR) | 05/01/2016 | 28/01/2021 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 asTherapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 399 | EUCTR2015-003123-57-LT (EUCTR) | 31/12/2015 | 17/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 400 | EUCTR2014-005217-24-CZ (EUCTR) | 22/12/2015 | 06/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 401 | JPRN-JapicCTI-163222 | 18/12/2015 | 08/04/2016 | Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Intervention name : Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 108 mg SC : Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab subcutaneous (SC), 108 mg, injection, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W), starting at Week 6 up to approximately Week 50. Intervention name : Vedolizumab IV, Placebo SC INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 300 mg IV: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50. Intervention name : Vedolizumab IV, Placebo IV, Placebo SC INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Placebo: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching SC injections, Q2W and placebo-matching IV infusions, Q8W starting at Week 6 up to approximately Week 50. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | 80 | BOTH | 383 | Phase 3 | Japan, Japan, Refer to Other section |
| 402 | NCT02611830 (ClinicalTrials.gov) | December 18, 2015 | 19/11/2015 | Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Drug: Vedolizumab 300 mg IV;Drug: Placebo IV;Drug: Vedolizumab 108 mg SC;Drug: Placebo SC | Takeda | NULL | Completed | 18 Years | 80 Years | All | 383 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic |
| 403 | EUCTR2014-005217-24-NL (EUCTR) | 17/12/2015 | 26/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 404 | EUCTR2015-002558-11-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 405 | EUCTR2015-002557-35-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia | ||
| 406 | NCT02531126 (ClinicalTrials.gov) | December 2, 2015 | 20/8/2015 | Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063 | Celgene | NULL | Active, not recruiting | 18 Years | 75 Years | All | 871 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;United Kingdom;Czech Republic;Spain |
| 407 | EUCTR2015-001022-42-IT (EUCTR) | 01/12/2015 | 29/03/2019 | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis | Active, Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: IBD98-M Delayed-release Capsules Product Code: IBD98-M INN or Proposed INN: SODIUM HYALURONATE Other descriptive name: SODIUM HYALURONATE INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-ASA | Holy Stone Healthcare Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 51 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 408 | NCT02586259 (ClinicalTrials.gov) | December 2015 | 23/10/2015 | Effectiveness of Cortiment® in Patients With Ulcerative Colitis | A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice | Ulcerative Colitis | Drug: budesonide MMX® | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 378 | Canada;Germany;Ireland;Italy;Netherlands;Poland;Sweden;United Kingdom;Israel;Switzerland | |
| 409 | EUCTR2015-001600-64-BE (EUCTR) | 30/11/2015 | 01/03/2016 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 410 | EUCTR2014-005217-24-GB (EUCTR) | 27/11/2015 | 22/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | United States;Belarus;Philippines;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Croatia;Romania;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 411 | EUCTR2015-000319-41-IT (EUCTR) | 19/11/2015 | 29/01/2021 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis. - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: NA Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | CELGENE INTERNATIONAL II SàRL | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 412 | EUCTR2014-005217-24-HU (EUCTR) | 19/11/2015 | 22/09/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 413 | EUCTR2015-001600-64-DE (EUCTR) | 13/11/2015 | 04/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 414 | EUCTR2014-005217-24-IE (EUCTR) | 12/11/2015 | 11/12/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | United Kingdom;Hungary;Austria;Turkey;Slovenia;Korea, Republic of;Moldova, Republic of;Netherlands;Latvia;South Africa;Australia;Malaysia;India;Vietnam;Switzerland;Colombia;Israel;Ireland;Ukraine;Spain;Slovakia;Hong Kong;Taiwan;Philippines;United States;Belarus;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 415 | EUCTR2014-005217-24-SK (EUCTR) | 12/11/2015 | 07/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 416 | EUCTR2014-005217-24-AT (EUCTR) | 06/11/2015 | 22/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden;Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain | ||
| 417 | EUCTR2014-005217-24-LV (EUCTR) | 06/11/2015 | 03/11/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 418 | JPRN-UMIN000019310 | 2015/11/01 | 01/11/2015 | Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis | ulcerative colitis | Arm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks) Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 weeks) | Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 90 | Not selected | Japan | |
| 419 | EUCTR2015-000319-41-SK (EUCTR) | 22/10/2015 | 04/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Latvia;South Africa;Australia;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia | ||
| 420 | EUCTR2015-001600-64-CZ (EUCTR) | 14/10/2015 | 31/07/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 421 | EUCTR2015-001600-64-SK (EUCTR) | 13/10/2015 | 27/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Djibouti;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 422 | EUCTR2015-001600-64-HU (EUCTR) | 12/10/2015 | 01/09/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sárl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 423 | EUCTR2015-000319-41-BE (EUCTR) | 06/10/2015 | 24/07/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 424 | EUCTR2015-001600-64-GB (EUCTR) | 28/09/2015 | 06/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (Clinical Study”) - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 425 | JPRN-JapicCTI-163122 | 24/9/2015 | 06/01/2016 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative, Inflammatory Bowel Diseases | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Janssen Pharmaceutical K.K. | NULL | complete | 18 | BOTH | 92 | Phase 3 | Japan, Asia except Japan, North America, Europe, Oceania | |
| 426 | EUCTR2015-000319-41-DE (EUCTR) | 18/09/2015 | 02/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 427 | EUCTR2015-000319-41-CZ (EUCTR) | 14/09/2015 | 16/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Germany;New Zealand;Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Austria;Korea, Republic of;Latvia;Netherlands;South Africa;Australia;Italy;Russian Federation;Israel;Ukraine;Spain;Greece;Slovakia;United States;Belarus | ||
| 428 | EUCTR2015-001954-14-NL (EUCTR) | 14/09/2015 | 25/08/2015 | Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial” | SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research | ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240 | Santeon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 429 | NCT02084550 (ClinicalTrials.gov) | September 2015 | 5/3/2014 | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial | Ulcerative Colitis | Dietary Supplement: Vaminolac;Other: Saline | Aarhus University Hospital | NULL | Active, not recruiting | 18 Years | 50 Years | All | 8 | N/A | Denmark |
| 430 | EUCTR2015-000319-41-GB (EUCTR) | 10/08/2015 | 13/07/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 431 | EUCTR2015-000319-41-HU (EUCTR) | 10/08/2015 | 05/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sárl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 432 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 433 | NCT04434872 (ClinicalTrials.gov) | July 2015 | 28/5/2015 | Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis | Ulcerative Colitis | Procedure: Colonoscopy;Procedure: Gastroscopy;Drug: Fecal Microbiota;Procedure: Enema | Tel-Aviv Sourasky Medical Center | NULL | Terminated | 18 Years | 70 Years | All | 80 | Phase 2 | Israel | |
| 434 | JPRN-UMIN000018075 | 2015/06/26 | 25/06/2015 | Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions | Ulcerative colitis | normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA no optimized therapy | Center for Diagnostic and Therapeutic Endoscopy,Keio University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan | |
| 435 | NCT02435992 (ClinicalTrials.gov) | June 17, 2015 | 24/4/2015 | Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063;Drug: Placebo | Celgene | NULL | Completed | 12 Years | 75 Years | All | 1012 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| 436 | NCT02463045 (ClinicalTrials.gov) | May 2015 | 26/5/2015 | Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects | A Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: TOP1288 | Topivert Pharma Ltd | NULL | Completed | 18 Years | 55 Years | All | 67 | Phase 1 | United Kingdom |
| 437 | EUCTR2013-000366-11-RO (EUCTR) | 25/03/2015 | 11/03/2015 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 438 | NCT02318667 (ClinicalTrials.gov) | February 27, 2015 | 12/12/2014 | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). | An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab. | Colitis, Ulcerative | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 65 Years | All | 38 | Phase 4 | Portugal |
| 439 | EUCTR2014-001893-32-PL (EUCTR) | 20/01/2015 | 22/10/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Belgium;Poland;Russian Federation;Germany | ||
| 440 | EUCTR2014-001893-32-CZ (EUCTR) | 19/01/2015 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany | ||
| 441 | NCT02261636 (ClinicalTrials.gov) | January 2015 | 7/10/2014 | Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment | Ulcerative Colitis | Drug: mesalazine | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 150 | Netherlands | ||
| 442 | EUCTR2014-001893-32-DE (EUCTR) | 15/12/2014 | 24/09/2014 | Placebo-controlled study to assess efficacy, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany | ||
| 443 | EUCTR2014-003262-25-PT (EUCTR) | 12/12/2014 | 20/11/2014 | Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab | An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 37 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal | ||
| 444 | EUCTR2014-001893-32-HU (EUCTR) | 08/12/2014 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany | ||
| 445 | EUCTR2014-001893-32-BE (EUCTR) | 24/11/2014 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany | ||
| 446 | NCT02246686 (ClinicalTrials.gov) | November 2014 | 19/9/2014 | Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients | A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: STW5-II (Iberogast N, BAY98-7410);Drug: Placebo | Bayer | NULL | Terminated | 18 Years | 80 Years | Both | 3 | Phase 2 | Germany |
| 447 | EUCTR2013-000263-88-RO (EUCTR) | 03/09/2014 | 30/05/2014 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not available Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not available Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not available Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 448 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 449 | EUCTR2013-000891-13-DE (EUCTR) | 21/07/2014 | 24/06/2014 | Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease) | A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Iberogast N Product Name: Iberogast N Product Code: STW5-II INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml Other descriptive name: BITTER CANDYTUFT FRESH PLANT EXTRACT INN or Proposed INN: Kümmel 2ml/10ml Other descriptive name: CARVI EXTRACTUM FLUIDUM INN or Proposed INN: Pfefferminzblätter 1ml/10ml Other descriptive name: MENTHA × PIPERITA L. FOLIUM INN or Proposed INN: Süßholzwurzel 1ml/10ml Other descriptive name: GLYCYRRHIZA GLABRA ROOT INN or Proposed INN: Kamillenblüten 3ml/10ml Other descriptive name: MATRICARIA RECUTITA L. FLOS INN or Proposed INN: Melissenblätter 15ml/10ml Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT | Steigerwald Arzneimittelwerk GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 450 | NCT02049502 (ClinicalTrials.gov) | July 2014 | 27/1/2014 | FMT in Ulcerative Colitis-Associated Pouchitis | The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis | Ulcerative Colitis Associated Pouchitis | Biological: biologically active human fecal microbiota;Procedure: sigmoidoscopy | Virginia O. Shaffer | NULL | Completed | 18 Years | 65 Years | All | 8 | Phase 2 | United States |
| 451 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 452 | EUCTR2013-000366-11-SK (EUCTR) | 19/06/2014 | 21/05/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 453 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 454 | EUCTR2013-000366-11-BG (EUCTR) | 23/04/2014 | 06/03/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 455 | EUCTR2013-004599-36-DE (EUCTR) | 23/04/2014 | 03/02/2014 | SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily | SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE | Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: SB012 INN or Proposed INN: hgd40 | sterna biologicals GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 456 | EUCTR2013-000263-88-BG (EUCTR) | 14/04/2014 | 17/02/2014 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 457 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 458 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 459 | NCT02913508 (ClinicalTrials.gov) | April 2014 | 22/9/2016 | Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease | A Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab intravenous injection;Drug: Vedolizumab subcutaneous injection | Takeda | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 2 | NULL |
| 460 | EUCTR2013-000366-11-LV (EUCTR) | 14/03/2014 | 07/02/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 461 | EUCTR2013-000366-11-LT (EUCTR) | 10/03/2014 | 22/01/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 462 | ChiCTR-TRC-14004153 | 2014-03-01 | 2014-01-03 | Research on Quality of Life in Patients with Ulcerative Colitis of type of sificiency of spleen and retention of damp-heat receiving Jian Pi Qing Chang [JPQC] decoction | Research on Quality of Life in Patients with Ulcerative Colitis of type of sificiency of spleen and retention of damp-heat receiving Jian Pi Qing Chang [JPQC] decoction | Ulcerative colitis | Western Medicine:5-ASA;TCM:Jian Pi Qing Chang [JPQC] decoction ; | Department of Gastroenterology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China | NULL | Completed | 18 | 75 | Both | Western Medicine:60;TCM:60; | I (Phase 1 study) | NULL |
| 463 | EUCTR2013-000366-11-HU (EUCTR) | 24/02/2014 | 28/11/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 464 | EUCTR2013-000263-88-PL (EUCTR) | 29/01/2014 | 26/11/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands | ||
| 465 | EUCTR2013-000263-88-NL (EUCTR) | 23/01/2014 | 21/11/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands | ||
| 466 | EUCTR2013-000263-88-HU (EUCTR) | 16/01/2014 | 21/11/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 467 | EUCTR2013-000263-88-BE (EUCTR) | 08/01/2014 | 29/10/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Ukraine;Russian Federation;Israel;France;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands | ||
| 468 | EUCTR2012-004366-18-BE (EUCTR) | 08/01/2014 | 27/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 469 | EUCTR2013-000263-88-DE (EUCTR) | 07/01/2014 | 14/10/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 470 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Completed | 18 Years | N/A | All | 81 | Phase 2 | France |
| 471 | JPRN-JapicCTI-142475 | 24/12/2013 | Phase 3 Clinical Trial with MD-0901 | Phase 3 Clinical Trial with MD-0901 | Mild to moderate active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks. Control intervention name : Asacol tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | NULL | 16 | BOTH | 250 | Phase 3 | NULL | |||
| 472 | EUCTR2012-004366-18-DE (EUCTR) | 17/12/2013 | 29/07/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany | ||
| 473 | EUCTR2013-000366-11-PL (EUCTR) | 12/12/2013 | 05/09/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 474 | EUCTR2012-004366-18-DK (EUCTR) | 11/12/2013 | 03/12/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands | ||
| 475 | EUCTR2012-004366-18-NL (EUCTR) | 28/11/2013 | 16/08/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands | ||
| 476 | NCT01959165 (ClinicalTrials.gov) | November 21, 2013 | 8/10/2013 | MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients | Ulcerative Colitis | Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo | AstraZeneca | NULL | Completed | 18 Years | 65 Years | All | 44 | Phase 2 | Japan | |
| 477 | EUCTR2012-002031-28-DE (EUCTR) | 05/11/2013 | 22/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 478 | EUCTR2012-002031-28-SE (EUCTR) | 09/10/2013 | 27/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 479 | EUCTR2013-000366-11-ES (EUCTR) | 07/10/2013 | 12/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden | |||
| 480 | EUCTR2012-002031-28-BG (EUCTR) | 03/10/2013 | 13/08/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapie, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 481 | JPRN-UMIN000010127 | 2013/09/24 | 01/04/2013 | Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis | ulcerative colitis | Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not applicable | Japan | |
| 482 | EUCTR2013-000366-11-CZ (EUCTR) | 12/09/2013 | 05/06/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 483 | EUCTR2013-000366-11-BE (EUCTR) | 02/09/2013 | 11/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 484 | NCT01941589 (ClinicalTrials.gov) | September 2013 | 30/8/2013 | Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis | Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids only | Sheba Medical Center | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 485 | EUCTR2013-000366-11-GB (EUCTR) | 30/08/2013 | 09/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 486 | EUCTR2011-004579-35-HR (EUCTR) | 27/08/2013 | 28/08/2014 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 487 | EUCTR2011-004580-79-HR (EUCTR) | 26/08/2013 | 28/08/2014 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 488 | EUCTR2011-004578-27-HR (EUCTR) | 26/08/2013 | 28/08/2014 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 489 | EUCTR2013-000366-11-FI (EUCTR) | 20/08/2013 | 05/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 490 | NCT01900574 (ClinicalTrials.gov) | August 9, 2013 | 12/7/2013 | A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 35 | Phase 1 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland |
| 491 | NCT01929668 (ClinicalTrials.gov) | August 2013 | 23/8/2013 | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study | Ulcerative Colitis | Drug: polyethylene glycol;Drug: Ascorbic Acid | Kyungpook National University | NULL | Completed | 18 Years | 80 Years | Both | 114 | N/A | Korea, Republic of |
| 492 | EUCTR2012-004366-18-AT (EUCTR) | 30/07/2013 | 12/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 493 | EUCTR2013-000366-11-IE (EUCTR) | 17/07/2013 | 16/05/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 494 | EUCTR2012-002031-28-HU (EUCTR) | 11/07/2013 | 15/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 495 | EUCTR2013-000366-11-DK (EUCTR) | 10/07/2013 | 10/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 496 | EUCTR2012-002031-28-ES (EUCTR) | 04/07/2013 | 10/06/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: . Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 497 | JPRN-UMIN000013892 | 2013/07/01 | 06/05/2014 | A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy | Ulcerative colitis and so on | AJG522 PEG plus E (Niflec®) | Gunma University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 80 | Phase 4 | Japan | |
| 498 | NCT01903252 (ClinicalTrials.gov) | July 2013 | 9/7/2013 | TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) | A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis | Acute Ulcerative Colitis | Drug: TP05;Drug: Asacol 400 mg | Tillotts Pharma AG | NULL | Completed | 18 Years | N/A | All | 817 | Phase 3 | Switzerland;Netherlands |
| 499 | EUCTR2013-000366-11-SE (EUCTR) | 28/06/2013 | 13/05/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 500 | EUCTR2012-002031-28-PL (EUCTR) | 18/06/2013 | 10/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 501 | EUCTR2012-002031-28-AT (EUCTR) | 11/06/2013 | 29/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 502 | JPRN-UMIN000010906 | 2013/06/10 | 10/06/2013 | The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. | Ulcerative Colitis | A 24-week administration of 4.8g/day of Asacol A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy | Chiba University Hospital | NULL | Complete: follow-up complete | 15years-old | 70years-old | Male and Female | 60 | Phase 2 | Japan | |
| 503 | NCT01914887 (ClinicalTrials.gov) | June 2013 | 18/7/2013 | Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis | A Phase I/IIa Clinical Trial to Evaluate Safety and Efficacy of Adipose Tissue-derived Mesenchymal Stem Cells (ASC) on Induction to Remission in Ulcerative Colitis | Ulcerative Colitis | Drug: Allogeneic adipose tissue-derived mesenchymal stem cells | Instituto de Investigación Hospital Universitario La Paz | Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz;Ministry of Health, Spain | Recruiting | 18 Years | N/A | Both | 8 | Phase 1/Phase 2 | Spain |
| 504 | EUCTR2012-002031-28-CZ (EUCTR) | 30/05/2013 | 16/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 505 | EUCTR2012-002031-28-NL (EUCTR) | 15/05/2013 | 22/02/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 506 | EUCTR2012-002031-28-IT (EUCTR) | 08/05/2013 | 01/07/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 507 | EUCTR2012-002031-28-SK (EUCTR) | 02/05/2013 | 05/02/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: PF-00547659 | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 508 | EUCTR2012-002031-28-BE (EUCTR) | 02/04/2013 | 01/02/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Sweden;New Zealand;Norway;Germany;Bulgaria;Croatia | ||
| 509 | NCT01771809 (ClinicalTrials.gov) | March 18, 2013 | 8/1/2013 | Long-Term Safety Of PF-00547659 In Ulcerative Colitis | A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II) | Ulcerative Colitis | Drug: 75mg SHP647 (PF-00547659);Drug: 225mg SHP647 (PF-00547659) | Shire | NULL | Completed | 18 Years | 66 Years | All | 330 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Czech Republic;Switzerland |
| 510 | EUCTR2011-004578-27-NL (EUCTR) | 04/03/2013 | 12/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada | |||
| 511 | NCT01831427 (ClinicalTrials.gov) | March 2013 | 8/4/2013 | Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis | A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: GS-5745;Drug: Placebo to match GS-5745 | Gilead Sciences | NULL | Completed | 18 Years | 65 Years | All | 74 | Phase 1 | United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania |
| 512 | NCT01768858 (ClinicalTrials.gov) | February 5, 2013 | 14/1/2013 | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Completed | 18 Years | 99 Years | All | 96 | Austria | |
| 513 | NCT01759056 (ClinicalTrials.gov) | February 2013 | 24/12/2012 | Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis | A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: AVX 470;Drug: Placebo | Avaxia Biologics, Incorporated | NULL | Completed | 18 Years | 75 Years | Both | 33 | Phase 1 | United States;Belgium;Canada;Hungary |
| 514 | EUCTR2011-004578-27-IT (EUCTR) | 18/01/2013 | 07/08/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulverative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan | |||
| 515 | EUCTR2011-004580-79-IT (EUCTR) | 18/01/2013 | 07/08/2012 | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | ulcerative colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib | PFIZER LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;New Zealand;Japan | ||
| 516 | NCT01839214 (ClinicalTrials.gov) | January 2013 | 21/4/2013 | A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: VB-201 160mg;Drug: Placebo | Vascular Biogenics Ltd. operating as VBL Therapeutics | NULL | Completed | 18 Years | N/A | Both | 112 | Phase 2 | Bulgaria;Hungary;Poland |
| 517 | NCT02922374 (ClinicalTrials.gov) | January 2013 | 28/9/2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | N/A | Both | 117 | Phase 1/Phase 2 | China |
| 518 | NCT04032652 (ClinicalTrials.gov) | December 2012 | 4/12/2012 | Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol | Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol | Ulcerative Colitis | Procedure: Rectal dialysis;Drug: Rectal dialysis | NorthShore University HealthSystem | NULL | Terminated | 18 Years | 45 Years | All | 2 | Phase 2 | NULL |
| 519 | EUCTR2010-023798-20-ES (EUCTR) | 29/11/2012 | 10/05/2012 | A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS | A PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU | MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ASC INN or Proposed INN: adipose tissue-derived mesenchymal stem cells Other descriptive name: aloASC | Fundacion para la Investigacion Biomedica Hospital Universitario La Paz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 520 | JPRN-UMIN000009364 | 2012/11/24 | 24/11/2012 | Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis | ulcerative colitis | Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years. | Graduate School of Medical Science, KyotoPrefectural University of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 2 | Japan | |
| 521 | EUCTR2011-004579-35-NL (EUCTR) | 10/10/2012 | 12/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | |||
| 522 | EUCTR2011-004578-27-PL (EUCTR) | 18/09/2012 | 20/06/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan | |||
| 523 | EUCTR2011-004579-35-PL (EUCTR) | 17/09/2012 | 28/06/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand | |||
| 524 | EUCTR2011-005115-82-LT (EUCTR) | 12/09/2012 | 24/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 525 | NCT01697670 (ClinicalTrials.gov) | September 2012 | 28/9/2012 | Photodynamic Therapy for Ulcerative Colitis | A Multicenter, Open Phase II Study to Assess the Effect and Safety of Low Dose Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis | Ulcerative Colitis | Drug: Photodynamic therapy with Gliolan | University of Zurich | Swiss National Science Foundation | Recruiting | 18 Years | N/A | Both | 7 | Phase 1 | Switzerland |
| 526 | EUCTR2011-004765-32-NL (EUCTR) | 27/08/2012 | 25/04/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE HYDROCHLORIDE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Belgium;Israel;Russian Federation;Netherlands;Italy | ||
| 527 | EUCTR2011-004580-79-PL (EUCTR) | 05/08/2012 | 12/06/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan | ||
| 528 | NCT01458574 (ClinicalTrials.gov) | July 20, 2012 | 21/10/2011 | A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: CP690,550;Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | N/A | All | 593 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 529 | EUCTR2011-004579-35-ES (EUCTR) | 11/07/2012 | 09/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | |||
| 530 | EUCTR2011-004578-27-ES (EUCTR) | 11/07/2012 | 09/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | |||
| 531 | NCT01612039 (ClinicalTrials.gov) | July 2012 | 1/6/2012 | Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: ASP3291;Drug: Placebo | Telsar Pharma Inc. | NULL | Completed | 18 Years | 65 Years | Both | 112 | Phase 2 | United States |
| 532 | EUCTR2011-004578-27-CZ (EUCTR) | 29/06/2012 | 08/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc | ,NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 533 | EUCTR2011-004579-35-CZ (EUCTR) | 29/06/2012 | 08/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc | ,NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | ||
| 534 | EUCTR2011-004770-28-AT (EUCTR) | 26/06/2012 | 15/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia | ||
| 535 | EUCTR2011-004580-79-CZ (EUCTR) | 26/06/2012 | 08/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy | ||
| 536 | EUCTR2011-005115-82-LV (EUCTR) | 15/06/2012 | 21/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 537 | EUCTR2010-022766-27-SK (EUCTR) | 11/06/2012 | 27/01/2012 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Italy;Sweden | ||
| 538 | EUCTR2011-004580-79-BE (EUCTR) | 08/06/2012 | 07/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 539 | EUCTR2011-004579-35-BE (EUCTR) | 08/06/2012 | 08/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | |||
| 540 | EUCTR2011-004580-79-DE (EUCTR) | 06/06/2012 | 28/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia | ||
| 541 | EUCTR2011-004578-27-BE (EUCTR) | 06/06/2012 | 07/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 542 | EUCTR2011-005115-82-EE (EUCTR) | 05/06/2012 | 09/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 543 | NCT01458951 (ClinicalTrials.gov) | June 2012 | 21/10/2011 | A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis. | Ulcerative Colitis | Drug: tofacitinib;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 547 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 544 | EUCTR2011-004578-27-HU (EUCTR) | 30/05/2012 | 10/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 545 | EUCTR2011-004579-35-DE (EUCTR) | 29/05/2012 | 21/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | ||
| 546 | EUCTR2011-004578-27-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 547 | EUCTR2011-004578-27-DE (EUCTR) | 23/05/2012 | 05/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not availble Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 548 | EUCTR2011-004579-35-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 549 | EUCTR2011-004580-79-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 550 | EUCTR2011-004580-79-ES (EUCTR) | 18/05/2012 | 09/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States | ||
| 551 | EUCTR2011-004578-27-AT (EUCTR) | 18/05/2012 | 27/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 552 | EUCTR2011-004579-35-AT (EUCTR) | 18/05/2012 | 21/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 553 | EUCTR2011-004580-79-AT (EUCTR) | 18/05/2012 | 27/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 554 | EUCTR2011-005115-82-BG (EUCTR) | 11/05/2012 | 11/04/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 555 | EUCTR2011-004580-79-HU (EUCTR) | 10/05/2012 | 10/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 556 | EUCTR2011-004579-35-HU (EUCTR) | 10/05/2012 | 10/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 557 | EUCTR2011-004770-28-DE (EUCTR) | 03/05/2012 | 09/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Propionylcarnitinhydrochlorid Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany | ||
| 558 | EUCTR2011-004580-79-SK (EUCTR) | 03/05/2012 | 10/04/2013 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 559 | EUCTR2011-004578-27-SK (EUCTR) | 02/05/2012 | 12/04/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Japan;Germany;Croatia;Romania;Belgium;Brazil;Poland;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;France;India | |||
| 560 | EUCTR2011-004579-35-SK (EUCTR) | 02/05/2012 | 13/04/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 561 | EUCTR2011-004579-35-GB (EUCTR) | 01/05/2012 | 12/01/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 562 | EUCTR2011-004580-79-GB (EUCTR) | 30/04/2012 | 14/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 563 | EUCTR2011-004578-27-GB (EUCTR) | 26/04/2012 | 12/01/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 564 | EUCTR2011-004578-27-EE (EUCTR) | 26/04/2012 | 14/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 565 | EUCTR2011-004765-32-IT (EUCTR) | 26/04/2012 | 23/07/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | SIGMA-TAU | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Belgium;Netherlands;Italy | ||
| 566 | EUCTR2011-004579-35-EE (EUCTR) | 26/04/2012 | 14/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 567 | EUCTR2011-004580-79-EE (EUCTR) | 26/04/2012 | 13/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 568 | EUCTR2011-005115-82-CZ (EUCTR) | 18/04/2012 | 08/02/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 569 | EUCTR2011-004812-40-GB (EUCTR) | 12/04/2012 | 21/03/2012 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;Italy;United Kingdom | ||
| 570 | EUCTR2011-004770-28-LT (EUCTR) | 12/04/2012 | 15/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany | ||
| 571 | EUCTR2011-005115-82-PL (EUCTR) | 10/04/2012 | 16/03/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 572 | NCT01465763 (ClinicalTrials.gov) | April 2012 | 21/10/2011 | A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis | Ulcerative Colitis | Drug: tofacitinib;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 614 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Brazil |
| 573 | EUCTR2010-022766-27-IT (EUCTR) | 28/03/2012 | 27/04/2012 | Study of safety and effectiveness of human-derived stem cells (multistem, also know as PF-05285401) in the treatment of ulcerative colitis. | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Multistem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: Multistem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten INN or Proposed INN: DEXTRAN 1 FOR INJECTION | PFIZER LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Canada;Belgium;Italy;Sweden | ||
| 574 | EUCTR2011-005115-82-HU (EUCTR) | 26/03/2012 | 07/02/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 575 | EUCTR2011-004770-28-HU (EUCTR) | 21/03/2012 | 23/01/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia | ||
| 576 | EUCTR2011-004770-28-PL (EUCTR) | 17/03/2012 | 16/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 15.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany | ||
| 577 | EUCTR2011-003130-14-IT (EUCTR) | 12/03/2012 | 05/03/2012 | Clinical Trial to assess the efficacy and safety of Kappaproct | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients” - CSUC-01/10 | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Product Code: DIMS0150 INN or Proposed INN: NA Other descriptive name: NA | INDEX PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 132 | Czech Republic;Hungary;Poland;Germany;United Kingdom;Italy | |||
| 578 | NCT01482884 (ClinicalTrials.gov) | March 2012 | 29/11/2011 | Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis | A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis | Ulcerative Colitis | Drug: tralokinumab;Drug: placebo | AstraZeneca | MedImmune Ltd | Completed | 18 Years | 65 Years | All | 147 | Phase 2 | Czech Republic;France;Germany;Italy;Poland;United Kingdom;Netherlands |
| 579 | EUCTR2011-004770-28-LV (EUCTR) | 29/02/2012 | 24/01/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Spain;Poland;Lithuania;Austria;Germany;Latvia | ||
| 580 | EUCTR2011-004770-28-ES (EUCTR) | 28/02/2012 | 11/01/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany | ||
| 581 | EUCTR2011-004579-35-DK (EUCTR) | 24/02/2012 | 24/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | ||
| 582 | EUCTR2011-004580-79-DK (EUCTR) | 24/02/2012 | 23/01/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 583 | EUCTR2011-004578-27-DK (EUCTR) | 24/02/2012 | 09/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 584 | EUCTR2011-004765-32-CZ (EUCTR) | 21/02/2012 | 15/12/2011 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Belgium;Netherlands;Italy | ||
| 585 | EUCTR2011-003532-32-LT (EUCTR) | 14/02/2012 | 28/11/2011 | A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis | Acute mild to moderate ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LX1606 Product Code: LX1606 INN or Proposed INN: Telotristat etiprate Other descriptive name: telotristat etiprate | Lexicon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovakia;Poland;Belgium;Lithuania | ||
| 586 | NCT01453491 (ClinicalTrials.gov) | February 13, 2012 | 13/10/2011 | A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis | A Phase 1b, Exploratory Study to Assess the Safety, Tolerability, Colonic Tissue Exposure, and Anti-Inflammatory Effects of Two Different Doses of SRT2104 in Subjects With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: SRT2104 | Sirtris, a GSK Company | GlaxoSmithKline | Completed | 18 Years | 75 Years | All | 17 | Phase 1 | United States |
| 587 | EUCTR2010-022766-27-BE (EUCTR) | 09/02/2012 | 08/11/2011 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 INN or Proposed INN: N/A Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 INN or Proposed INN: N/A Other descriptive name: Multistem Trade Name: Promiten INN or Proposed INN: Dextran Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Germany;Italy;Sweden | ||
| 588 | EUCTR2010-022766-27-HU (EUCTR) | 07/02/2012 | 05/12/2011 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden | ||
| 589 | NCT01456052 (ClinicalTrials.gov) | January 30, 2012 | 17/10/2011 | A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Telotristat Etiprate;Drug: Placebo | Lexicon Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 59 | Phase 2 | United States;Lithuania;Poland;Slovakia |
| 590 | NCT01532648 (ClinicalTrials.gov) | January 27, 2012 | 13/12/2011 | Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis | Drug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASA | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic |
| 591 | EUCTR2011-004812-40-DE (EUCTR) | 26/01/2012 | 25/11/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;United Kingdom;Italy | ||
| 592 | EUCTR2011-004812-40-NL (EUCTR) | 25/01/2012 | 22/12/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;United Kingdom;Italy | ||
| 593 | EUCTR2011-004812-40-CZ (EUCTR) | 24/01/2012 | 29/12/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;United Kingdom;Italy | ||
| 594 | EUCTR2010-022766-27-SE (EUCTR) | 19/01/2012 | 03/11/2011 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden | ||
| 595 | EUCTR2011-004765-32-SK (EUCTR) | 19/01/2012 | 09/12/2011 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Slovakia;Belgium;Netherlands;Italy | ||
| 596 | EUCTR2011-003130-14-CZ (EUCTR) | 13/01/2012 | 14/10/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct INN or Proposed INN: DIMS0150 Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;Czech Republic;Poland;Germany;Italy;United Kingdom | |||
| 597 | EUCTR2011-004765-32-BE (EUCTR) | 10/01/2012 | 06/12/2011 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Slovakia;Belgium;Netherlands;Italy | ||
| 598 | EUCTR2011-003283-78-IT (EUCTR) | 09/01/2012 | 01/03/2012 | A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS | A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS | Active Ulcerative Colitis Patients MedDRA version: 14.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: GED-0507-34-Levo INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid Other descriptive name: NA | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 599 | EUCTR2011-002462-20-IT (EUCTR) | 02/01/2012 | 08/03/2012 | Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis. | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis:PoC study | mild to moderate ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Lysine-D-proline-threonine Product Code: K(D)PT INN or Proposed INN: NA Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate | DR. AUGUST WOLFF GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | |||
| 600 | EUCTR2011-003130-14-DE (EUCTR) | 30/12/2011 | 19/09/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct INN or Proposed INN: DIMS0150 Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | |||
| 601 | EUCTR2011-003130-14-PL (EUCTR) | 22/12/2011 | 10/10/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | |||
| 602 | EUCTR2010-020448-37-NL (EUCTR) | 21/12/2011 | 16/09/2010 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE | Enceladus Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Belgium;Netherlands | ||
| 603 | EUCTR2011-003532-32-SK (EUCTR) | 19/12/2011 | 10/11/2011 | A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis | Acute mild to moderate ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LX1606 Product Code: LX1606 INN or Proposed INN: Non as of yet Other descriptive name: telotristat etiprate | Lexicon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovakia;Belgium;Poland;Lithuania | ||
| 604 | EUCTR2011-004268-31-DK (EUCTR) | 13/12/2011 | 21/11/2011 | Adalimumab (Humira) in the treatment of chronic pouchitis | Adalimumab (Humira) in the treatment of chronic pouchitis | Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringes Product Name: Humira Product Code: EMEA/H/C/000481 | Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Denmark | ||
| 605 | EUCTR2011-004812-40-IT (EUCTR) | 12/12/2011 | 02/03/2012 | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab Other descriptive name: NA | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;United Kingdom;Italy | ||
| 606 | NCT01496053 (ClinicalTrials.gov) | December 2011 | 15/12/2011 | Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD) | Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study | Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract | Oslo University Hospital | ImmunoPharma AS | Completed | 18 Years | 60 Years | All | 100 | Phase 2/Phase 3 | Norway |
| 607 | NCT01493960 (ClinicalTrials.gov) | December 2011 | 12/12/2011 | The Efficacy and Safety of Kappaproct in Chronic Active Treatment Refractory Ulcerative Colitis Patients | A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Kappaproct as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients | Colitis, Ulcerative | Drug: Kappaproct;Drug: Placebo | InDex Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 131 | Phase 3 | Czech Republic;France;Germany;Hungary;Italy;Poland;United Kingdom |
| 608 | EUCTR2011-003130-14-HU (EUCTR) | 14/10/2011 | 01/09/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | |||
| 609 | EUCTR2011-003130-14-GB (EUCTR) | 06/10/2011 | 11/08/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | ||
| 610 | NCT01346826 (ClinicalTrials.gov) | May 2011 | 2/5/2011 | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD) | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial | Crohn's Disease;Ulcerative Colitis | Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion | Asan Medical Center | NULL | Completed | 16 Years | 80 Years | Both | 145 | Phase 4 | Korea, Republic of |
| 611 | NCT01341808 (ClinicalTrials.gov) | April 2011 | 25/4/2011 | Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients | Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis A | Biological: Epaxal Berna (virosomal hepatitis A vaccine) | Asan Medical Center | NULL | Completed | 18 Years | 40 Years | Both | 493 | Phase 4 | Korea, Republic of |
| 612 | EUCTR2010-019558-42-SK (EUCTR) | 23/02/2011 | 27/10/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Hungary;Czech Republic;Slovakia;Belgium | ||
| 613 | EUCTR2010-023494-19-SE (EUCTR) | 10/02/2011 | 27/12/2010 | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Lysine-D-Proline-Threonine Product Code: K(D)PT | Dr. August Wolff GmbH & Co. KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 614 | NCT01290042 (ClinicalTrials.gov) | February 2011 | 27/1/2011 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. | A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease. | Ulcerative Colitis;Crohn's Disease | Drug: AMG 181;Other: Placebo for AMG 181 | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia |
| 615 | EUCTR2010-019558-42-HU (EUCTR) | 20/01/2011 | 10/11/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | |||
| 616 | EUCTR2010-019558-42-CZ (EUCTR) | 10/01/2011 | 25/10/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | |||
| 617 | EUCTR2010-019558-42-BE (EUCTR) | 23/12/2010 | 13/10/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | |||
| 618 | EUCTR2010-020448-37-BE (EUCTR) | 10/12/2010 | 22/12/2010 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE | Enceladus Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Belgium;Netherlands | ||
| 619 | NCT01257399 (ClinicalTrials.gov) | November 2010 | 8/12/2010 | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | Ulcerative Colitis in Remission | Drug: Asacol®;Drug: Mesalazine | Tillotts Pharma AG | Zeria Pharmaceutical | Completed | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 620 | NCT01257386 (ClinicalTrials.gov) | November 2010 | 8/12/2010 | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: Asacol®;Drug: Mesalazine | Tillotts Pharma AG | Zeria Pharmaceutical | Completed | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 621 | NCT01111292 (ClinicalTrials.gov) | October 2010 | 24/4/2010 | Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia | Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia | Colon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal Carcinoma | Drug: Inositol;Other: Placebo | National Cancer Institute (NCI) | NULL | Terminated | 18 Years | N/A | All | 5 | Phase 1/Phase 2 | United States |
| 622 | NCT01320332 (ClinicalTrials.gov) | August 2010 | 15/3/2011 | A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis | A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: ASP3291;Drug: Placebo | Telsar Pharma Inc. | NULL | Completed | 18 Years | 65 Years | Both | 16 | Phase 1 | United States |
| 623 | JPRN-UMIN000003785 | 2010/07/01 | 01/07/2010 | Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. | Ulcerative colitis | 5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). 5-aminosalicylic acid monotherapy and tacrolimus arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule. | Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan | |
| 624 | NCT01164904 (ClinicalTrials.gov) | July 2010 | 1/7/2010 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Amg 181 | Amgen | NULL | Terminated | 18 Years | 55 Years | Both | 72 | Phase 1 | United States;Australia;New Zealand |
| 625 | EUCTR2009-013890-16-PT (EUCTR) | 28/05/2010 | 21/12/2009 | Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica | Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica | This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 | Trade Name: Remicade Product Name: Remicade | GEDII - Grupo de Estudo da Doença inflamatória Intestinal | NULL | Not Recruiting | Female: yes Male: yes | 20 | Portugal | |||
| 626 | EUCTR2009-015077-12-GB (EUCTR) | 23/11/2009 | 17/09/2009 | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 627 | NCT01059344 (ClinicalTrials.gov) | November 2009 | 28/1/2010 | Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis | A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamin | Tillotts Pharma AG | NULL | Completed | 18 Years | N/A | All | 281 | Phase 3 | Belarus;India;Turkey;Ukraine |
| 628 | EUCTR2009-011608-51-DE (EUCTR) | 09/10/2009 | 21/07/2009 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | |||
| 629 | NCT03747068 (ClinicalTrials.gov) | October 9, 2009 | 12/11/2018 | The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease. | Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis | Ulcerative Colitis;Anti TNF Therapy;Ileal Pouch Anal Anastomosis (IPAA) | Drug: Anti-TNF Drug | HaEmek Medical Center, Israel | Mount Sinai Hospital, Canada;University of Toronto | Completed | N/A | N/A | All | 130 | NULL | |
| 630 | NCT01004185 (ClinicalTrials.gov) | October 2009 | 27/10/2009 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Terminated | 5 Years | 17 Years | All | 39 | Phase 3 | United States;Canada;Croatia;Poland;Romania;Russian Federation |
| 631 | EUCTR2004-004184-29-DK (EUCTR) | 10/09/2009 | 10/10/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 632 | EUCTR2009-010921-38-NL (EUCTR) | 08/09/2009 | 02/03/2009 | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Ulcerative Colitis and the risk of developing colorectal cancer. MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Salofalk INN or Proposed INN: mesalazine Trade Name: Ursofalk INN or Proposed INN: ursodeoxycholic acid | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 633 | EUCTR2009-010065-23-DE (EUCTR) | 17/08/2009 | 14/04/2009 | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone | Essex Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 634 | EUCTR2009-011608-51-SE (EUCTR) | 17/08/2009 | 22/06/2009 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | |||
| 635 | EUCTR2009-011608-51-BE (EUCTR) | 03/08/2009 | 23/06/2009 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belgium;Germany;Sweden | ||
| 636 | NCT01149694 (ClinicalTrials.gov) | June 2009 | 22/6/2010 | A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers | A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers | Ulcerative Colitis | Drug: PUR 0110 Rectal Enema or Placebo Enema | PurGenesis Technologies Inc. | NULL | Completed | 18 Years | 55 Years | Male | 24 | Phase 1 | Germany |
| 637 | EUCTR2008-007519-34-SE (EUCTR) | 17/04/2009 | 02/03/2009 | Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION | Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION | This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with | Trade Name: Remicade | University of Leuven Hospitals, Division of Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Sweden | |||
| 638 | EUCTR2008-007292-25-IT (EUCTR) | 24/03/2009 | 16/03/2009 | AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 | AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 | Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure) MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis | Trade Name: MEZAVANT INN or Proposed INN: Mesalazine Trade Name: ASACOL INN or Proposed INN: Mesalazine | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 639 | NCT00713310 (ClinicalTrials.gov) | December 2008 | 9/7/2008 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis | Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Completed | 5 Years | 17 Years | All | 83 | Phase 3 | United States;Canada;Croatia;Poland;Romania |
| 640 | NCT00793130 (ClinicalTrials.gov) | November 2008 | 16/11/2008 | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | Ulcerative Colitis | Dietary Supplement: Coltect | Tel-Aviv Sourasky Medical Center | NULL | Recruiting | 18 Years | 75 Years | Both | 30 | N/A | Israel |
| 641 | NCT00751933 (ClinicalTrials.gov) | October 2008 | 11/9/2008 | Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis | A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis. | Ulcerative Colitis | Biological: Vaccine Vivotif + Vaccine Dukoral + oats;Biological: Vaccine Vivotif + Vaccine Dukoral;Dietary Supplement: Oats;Other: Placebo | Haukeland University Hospital | Helse Vest | Terminated | 18 Years | 80 Years | All | 3 | Phase 2 | Norway |
| 642 | EUCTR2006-003399-37-DK (EUCTR) | 25/09/2008 | 10/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 643 | ChiCTR-TRC-08000145 | 2008-09-01 | 2008-08-25 | The study of the treatment and rehabilitation of ulcerative colitis | The study of the treatment and rehabilitation of ulcerative colitis | Ulcerative Colitis | 1:5-ASA and low residue diet;2:5-ASA and EN;3:5-ASA and low residue diet and microecology prepar;4:5-ASA and low residue diet ang Gln;5:5-ASA and EN and Gln and microecology preparation; | Friendship Hospital of Capital Medical University | NULL | Completed | 18 | 70 | Both | 1:60;2:60;3:60;4:60;5:60; | I (Phase 1 study) | China |
| 644 | NCT00694980 (ClinicalTrials.gov) | September 2008 | 7/6/2008 | A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis | A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: placebo;Drug: rhuMAb Beta7 | Genentech, Inc. | NULL | Completed | 18 Years | 70 Years | Both | 48 | Phase 1 | United States;Belgium;Canada;Germany;Netherlands;United Kingdom |
| 645 | EUCTR2006-003399-37-SE (EUCTR) | 26/08/2008 | 21/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 646 | EUCTR2007-005166-12-DE (EUCTR) | 29/07/2008 | 15/01/2008 | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) | Hutchison MediPharma Enterprises Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Germany | ||
| 647 | EUCTR2006-002670-22-GB (EUCTR) | 11/06/2008 | 01/08/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 648 | NCT00679432 (ClinicalTrials.gov) | June 2008 | 14/5/2008 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg. | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Canada;India;Mexico |
| 649 | EUCTR2007-004732-23-PL (EUCTR) | 05/05/2008 | 12/05/2008 | A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) | A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 650 | EUCTR2007-004732-23-LV (EUCTR) | 27/02/2008 | 28/02/2008 | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 651 | EUCTR2006-002670-22-SK (EUCTR) | 08/02/2008 | 15/04/2008 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 652 | EUCTR2006-003399-37-NL (EUCTR) | 17/01/2008 | 08/10/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 653 | EUCTR2004-004184-29-NL (EUCTR) | 15/01/2008 | 17/10/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 654 | NCT01045018 (ClinicalTrials.gov) | January 2008 | 17/12/2009 | A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis | BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: Placebo;Drug: Mesalamine | EMET Pharmaceuticals, LLC | Eagle Pharmaceuticals, Inc. | Completed | 18 Years | N/A | Both | Phase 3 | NULL | |
| 655 | EUCTR2004-004184-29-PT (EUCTR) | 14/12/2007 | 11/10/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 656 | EUCTR2006-002670-22-IT (EUCTR) | 27/11/2007 | 04/10/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: Infliximab Trade Name: imuran INN or Proposed INN: azathioprine | SCHERING-PLOUGH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy | |||
| 657 | EUCTR2006-003399-37-DE (EUCTR) | 27/11/2007 | 03/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 658 | EUCTR2004-004184-29-SE (EUCTR) | 22/11/2007 | 27/09/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 659 | EUCTR2006-003399-37-BE (EUCTR) | 15/11/2007 | 18/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 660 | EUCTR2006-002670-22-DE (EUCTR) | 31/10/2007 | 12/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 661 | EUCTR2007-002542-38-DE (EUCTR) | 29/10/2007 | 22/02/2008 | A clinical study to explore the safe and effective use of the drugsotrastaurin in patients with ulcerative colitis | A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: AEB071A Trade Name: B2-ASmedic Product Name: B2-ASmedic INN or Proposed INN: RIBOFLAVIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Denmark;Germany | |||
| 662 | EUCTR2007-004732-23-EE (EUCTR) | 22/10/2007 | 23/10/2007 | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 663 | EUCTR2006-002670-22-PT (EUCTR) | 12/10/2007 | 20/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 664 | NCT00603733 (ClinicalTrials.gov) | October 2007 | 16/1/2008 | Canadian Active & Maintenance Modified Pentasa Study | A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks | Active Ulcerative Colitis;Remission of Ulcerative Colitis | Drug: 5-ASA (5-Aminosalicylate) | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 288 | Phase 3 | Canada |
| 665 | EUCTR2006-003399-37-AT (EUCTR) | 27/09/2007 | 17/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 666 | EUCTR2006-002670-22-FR (EUCTR) | 07/09/2007 | 14/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 667 | EUCTR2006-003399-37-LV (EUCTR) | 03/09/2007 | 04/09/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan | ||
| 668 | EUCTR2006-002670-22-CZ (EUCTR) | 29/08/2007 | 20/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy | |||
| 669 | EUCTR2006-002670-22-HU (EUCTR) | 09/08/2007 | 04/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 670 | EUCTR2006-002670-22-BE (EUCTR) | 25/07/2007 | 15/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 671 | NCT00537316 (ClinicalTrials.gov) | July 2007 | 28/9/2007 | Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Ulcerative Colitis | Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion | Merck Sharp & Dohme Corp. | NULL | Terminated | 21 Years | N/A | All | 242 | Phase 3 | Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 672 | NCT00505778 (ClinicalTrials.gov) | July 2007 | 20/7/2007 | A Comparison of Once a Day Dose Compared to 2 Doses/Day | A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine Once-Daily;Drug: Mesalamine Twice-Daily | Warner Chilcott | NULL | Completed | 18 Years | N/A | All | 1027 | Phase 3 | United States;Canada;Puerto Rico |
| 673 | JPRN-UMIN000004401 | 2007/06/01 | 18/10/2010 | A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis | Ulcerative colitis (Proctitis type) | Placebo arm: A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks). True arm: A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study period | Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 30 | Phase 2,3 | Japan | |
| 674 | NCT00446849 (ClinicalTrials.gov) | May 1, 2007 | 12/3/2007 | Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) | A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | NULL | Completed | 18 Years | N/A | All | 290 | Phase 4 | United States |
| 675 | NCT00467922 (ClinicalTrials.gov) | May 2007 | 27/4/2007 | An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy | A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid | Crohn's Disease;Ulcerative Colitis;Rectal Cancer;Colon Cancer;Colon Polyps;Rectal Polyps;Diverticulitis | Drug: Hextend;Drug: Lactated Ringers | Spectrum Health Hospitals | Deltex Medical, Inc. | Completed | 18 Years | 80 Years | Both | 69 | Phase 3 | United States |
| 676 | EUCTR2005-005363-28-HU (EUCTR) | 25/01/2007 | 25/09/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | |||
| 677 | EUCTR2005-005363-28-AT (EUCTR) | 08/01/2007 | 10/01/2007 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | |||
| 678 | EUCTR2006-001782-42-HU (EUCTR) | 20/12/2006 | 16/08/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Other descriptive name: PARNAPARIN SODIUM | Cosmo Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | |||
| 679 | EUCTR2006-001782-42-IT (EUCTR) | 03/11/2006 | 20/12/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND | Patients with mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: CB-01-05-MMX | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | |||
| 680 | EUCTR2006-001782-42-GB (EUCTR) | 17/10/2006 | 29/09/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Other descriptive name: PARNAPARIN SODIUM | Cosmo Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Italy;United Kingdom | ||
| 681 | NCT00951548 (ClinicalTrials.gov) | October 2006 | 2/8/2009 | Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis | Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study | Ulcerative Colitis | Dietary Supplement: VSL#3;Dietary Supplement: Placebo | VSL Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 144 | N/A | Italy |
| 682 | NCT00708656 (ClinicalTrials.gov) | October 2006 | 8/4/2008 | The Colitis Once Daily Asacol Study | A Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis. | Ulcerative Colitis | Drug: mesalazine (Asacol®) | Cardiff and Vale University Health Board | Procter and Gamble | Completed | 18 Years | N/A | All | 213 | Phase 3 | United Kingdom |
| 683 | NCT00643071 (ClinicalTrials.gov) | September 2006 | 20/3/2008 | Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study | Ulcerative Colitis | Drug: Tacrolimus | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 32 | Phase 3 | Japan |
| 684 | NCT00347048 (ClinicalTrials.gov) | September 2006 | 30/6/2006 | Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Ulcerative Colitis | Drug: tacrolimus;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 62 | Phase 3 | Japan |
| 685 | NCT00343850 (ClinicalTrials.gov) | September 2006 | 21/6/2006 | Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis | Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot Trial | Ulcerative Colitis | Drug: Asacol (mesalamine) | University of Chicago | Procter and Gamble | Completed | 18 Years | N/A | Both | 30 | Phase 3 | United States |
| 686 | EUCTR2005-005363-28-BE (EUCTR) | 22/08/2006 | 27/04/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | |||
| 687 | EUCTR2006-001310-32-LT (EUCTR) | 17/07/2006 | 15/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 688 | EUCTR2005-005363-28-GB (EUCTR) | 11/07/2006 | 17/01/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom | ||
| 689 | NCT00349388 (ClinicalTrials.gov) | July 2006 | 5/7/2006 | Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients | A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol | Annette Langseder | Procter and Gamble | Terminated | 6 Years | 18 Years | All | 1 | N/A | United States |
| 690 | EUCTR2006-001310-32-HU (EUCTR) | 29/06/2006 | 23/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 691 | EUCTR2006-001310-32-CZ (EUCTR) | 26/06/2006 | 17/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 692 | EUCTR2006-001310-32-EE (EUCTR) | 16/06/2006 | 27/04/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 693 | NCT00350415 (ClinicalTrials.gov) | June 2006 | 6/7/2006 | A Double Blind Study for the Treatment of Acute Ulcerative Colitis | A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalamine | Warner Chilcott | NULL | Completed | 18 Years | 75 Years | Both | 772 | Phase 3 | United States;Belarus;Canada;Croatia;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro |
| 694 | EUCTR2005-005363-28-CZ (EUCTR) | 15/05/2006 | 18/04/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;United Kingdom;Czech Republic;Belgium;Austria | |||
| 695 | EUCTR2005-005363-28-DE (EUCTR) | 02/05/2006 | 02/06/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Czech Republic;United Kingdom;Germany;Belgium;Austria | |||
| 696 | NCT00408174 (ClinicalTrials.gov) | May 2006 | 4/12/2006 | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide disodium | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 400 | Phase 3 | United States |
| 697 | EUCTR2006-001310-32-LV (EUCTR) | 28/04/2006 | 22/08/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III | Ulcerative Colitis | Product Name: Asacol 800mg tablet INN or Proposed INN: mesalazine Product Name: Asacol 400mg tablet INN or Proposed INN: mesalazine | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 470 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 698 | EUCTR2005-002784-91-GB (EUCTR) | 06/02/2006 | 24/11/2005 | A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) | A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Cardiff and Vale NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 630 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 699 | NCT00269438 (ClinicalTrials.gov) | December 2005 | 22/12/2005 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 80 Years | All | 225 | Phase 3 | United States |
| 700 | NCT00254618 (ClinicalTrials.gov) | October 2005 | 14/11/2005 | A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis. | Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis. | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | NULL | Terminated | 5 Years | 17 Years | Both | 34 | Phase 1 | United States |
| 701 | EUCTR2005-000695-40-GB (EUCTR) | 27/09/2005 | 17/08/2005 | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | The medical condition is Ulcerative Colitis. | Product Name: products containing azathioprine or 6-mercaptopurine INN or Proposed INN: azathioprine INN or Proposed INN: azathioprine INN or Proposed INN: 6-mercaptopurine Product Name: Products containing aminosalicylate INN or Proposed INN: Sulphsalazine, Pentasa, Asacol, Colazide, Depentum | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 702 | EUCTR2004-000734-36-CZ (EUCTR) | 13/07/2005 | 08/10/2004 | A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. | A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. | Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study | Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA) | Shire Pharmaceutical Development Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | Czech Republic | ||
| 703 | EUCTR2004-004184-29-DE (EUCTR) | 06/06/2005 | 01/03/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis | Product Name: None given Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 3 | Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden | ||
| 704 | EUCTR2004-001677-26-IT (EUCTR) | 06/06/2005 | 15/02/2006 | Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study | Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study | Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: Nolpitantium Besylate Product Code: SR140333B | SANOFI-SYNTHELABO | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 705 | EUCTR2004-004184-29-GB (EUCTR) | 31/05/2005 | 23/02/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 706 | EUCTR2004-004184-29-ES (EUCTR) | 05/05/2005 | 03/04/2006 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. | Ulcerative colitis MedDRA version: 3.2;Level: LLT;Classification code 10045365 | Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 707 | EUCTR2004-004077-29-SK (EUCTR) | 25/04/2005 | 01/02/2005 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Slovakia;Lithuania;Germany;United Kingdom | ||
| 708 | EUCTR2004-004184-29-CZ (EUCTR) | 13/04/2005 | 11/04/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden | ||
| 709 | NCT00151892 (ClinicalTrials.gov) | April 8, 2005 | 7/9/2005 | Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis | A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: SPD476;Drug: Asacol | Shire | NULL | Completed | 18 Years | N/A | All | 829 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czechia;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic |
| 710 | EUCTR2004-004184-29-HU (EUCTR) | 30/03/2005 | 10/02/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 711 | EUCTR2004-001677-26-EE (EUCTR) | 23/03/2005 | 23/03/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 712 | EUCTR2004-004077-29-GB (EUCTR) | 18/02/2005 | 23/02/2005 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Technical Centres Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Lithuania;Germany;United Kingdom | |||
| 713 | EUCTR2004-004077-29-LT (EUCTR) | 09/02/2005 | 22/12/2004 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | |||
| 714 | EUCTR2004-001677-26-SE (EUCTR) | 07/02/2005 | 23/12/2004 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 715 | EUCTR2004-004077-29-DE (EUCTR) | 04/02/2005 | 22/12/2004 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | |||
| 716 | EUCTR2004-004077-29-CZ (EUCTR) | 03/02/2005 | 03/02/2005 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Czech Republic;Lithuania | |||
| 717 | EUCTR2004-001677-26-HU (EUCTR) | 25/01/2005 | 03/11/2004 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Estonia;Czech Republic;Hungary;Spain;Italy;Sweden | ||
| 718 | EUCTR2004-001677-26-ES (EUCTR) | 14/01/2005 | 01/06/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 719 | EUCTR2004-000611-25-IE (EUCTR) | 19/10/2004 | 16/08/2004 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 720 | EUCTR2004-000611-25-HU (EUCTR) | 15/10/2004 | 21/07/2004 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 721 | EUCTR2004-000916-25-IT (EUCTR) | 28/09/2004 | 18/05/2005 | A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS | A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS | TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION MedDRA version: 6.1;Level: PT;Classification code 10021972 | Product Name: 5-ASA MMx INN or Proposed INN: Mesalazine | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 722 | EUCTR2004-000733-12-CZ (EUCTR) | 14/07/2004 | 01/07/2004 | A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. | A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. | Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses | Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA) | Shire Pharmaceutical Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | Czech Republic | ||
| 723 | NCT00092508 (ClinicalTrials.gov) | May 2004 | 22/9/2004 | CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission | Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission | Ulcerative Colitis | Drug: OPC-6535;Drug: Asacol® | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 1725 | Phase 3 | United States |
| 724 | EUCTR2004-001677-26-CZ (EUCTR) | 09/03/2004 | 10/02/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 725 | NCT00548574 (ClinicalTrials.gov) | December 4, 2003 | 23/10/2007 | Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: Mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 343 | Phase 3 | Belgium |
| 726 | NCT00503243 (ClinicalTrials.gov) | September 30, 2003 | 16/7/2007 | Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: Delayed and extended release mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 280 | Phase 3 | United States |
| 727 | NCT00194818 (ClinicalTrials.gov) | June 2003 | 15/9/2005 | Asacol Dosing Study for Active Ulcerative Colitis | Open Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs. Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol (mesalamine) | University of Washington | Procter and Gamble | Completed | 18 Years | 80 Years | Both | 7 | Phase 4 | United States |
| 728 | NCT00510978 (ClinicalTrials.gov) | January 2002 | 2/8/2007 | Probiotics in GastroIntestinal Disorders | One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis | Ulcerative Colitis;Crohn's Disease | Biological: Bifidobacterium infantis 35624;Biological: Lactobacillus salivarius UCC118;Biological: Placebo | University College Cork | European Commission | Active, not recruiting | N/A | 75 Years | Both | 360 | Phase 2/Phase 3 | Ireland |
| 729 | NCT00577473 (ClinicalTrials.gov) | February 2001 | 19/12/2007 | Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) | A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | NULL | Completed | 18 Years | 65 Years | All | 301 | Phase 3 | United States |
| 730 | NCT00073021 (ClinicalTrials.gov) | September 2000 | 13/11/2003 | Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis | A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 800 mg (mesalamine);Drug: Asacol 400 mg (mesalamine) | Warner Chilcott | NULL | Completed | 18 Years | 75 Years | All | 386 | Phase 3 | United States;Canada;Puerto Rico |
| 731 | EUCTR2017-000573-37-BE (EUCTR) | 14/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | |||
| 732 | EUCTR2018-003985-15-PL (EUCTR) | 02/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 733 | EUCTR2019-004224-38-PL (EUCTR) | 04/12/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Belgium;Poland;Russian Federation;Germany;United Kingdom;Japan | |||
| 734 | EUCTR2017-000572-28-IE (EUCTR) | 04/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Japan;Bulgaria;Belgium;Argentina;Canada;Mexico;Hungary;France;Switzerland;Colombia;Turkey;Lebanon;Ireland;Ukraine;Spain;Greece;Slovakia;Portugal;United States | |||
| 735 | EUCTR2018-003985-15-DE (EUCTR) | 01/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Serbia;Belarus;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 736 | EUCTR2018-003986-33-PL (EUCTR) | 15/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany | |||
| 737 | EUCTR2015-001600-64-PL (EUCTR) | 03/12/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | NA | Female: yes Male: yes | 1350 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | |||
| 738 | EUCTR2016-001392-78-IT (EUCTR) | 12/02/2021 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis - NA | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden | |||
| 739 | EUCTR2018-003986-33-DE (EUCTR) | 19/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 740 | EUCTR2015-000319-41-BG (EUCTR) | 12/08/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | |||
| 741 | EUCTR2017-000599-27-PL (EUCTR) | 04/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;New Zealand;Japan | |||
| 742 | EUCTR2018-003986-33-CZ (EUCTR) | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 743 | EUCTR2018-003986-33-EE (EUCTR) | 19/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | |||
| 744 | EUCTR2012-004366-18-FR (EUCTR) | 28/09/2015 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | |||
| 745 | EUCTR2015-000319-41-PL (EUCTR) | 16/09/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | |||
| 746 | EUCTR2017-000573-37-PL (EUCTR) | 01/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;United States | |||
| 747 | EUCTR2007-005702-49-PL (EUCTR) | 17/06/2009 | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II | Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term: | Trade Name: Asacol Product Name: Asacol Product Code: NA INN or Proposed INN: MESALAZINE | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Poland | |||
| 748 | EUCTR2019-004224-38-Outside-EU/EEA (EUCTR) | 25/01/2021 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | Phase 3 | Japan;Russian Federation;United States;Belgium;Germany;Hungary;Poland;United Kingdom | ||||
| 749 | EUCTR2018-003985-15-BE (EUCTR) | 08/05/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 750 | EUCTR2016-004676-22-PL (EUCTR) | 15/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 942 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | |||
| 751 | EUCTR2019-004224-38-BE (EUCTR) | 19/04/2021 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | |||
| 752 | EUCTR2020-004300-34-CZ (EUCTR) | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | |||
| 753 | EUCTR2020-004300-34-BE (EUCTR) | 26/01/2022 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 754 | EUCTR2019-004224-38-GB (EUCTR) | 25/11/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom | |||
| 755 | JPRN-JapicCTI-060298 | 24/08/2006 | Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis | Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion | Mitsubishi Tanabe Pharma Corporation | NULL | 16 | BOTH | Phase 3 | NULL |