97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04991324
(ClinicalTrials.gov)
September 202227/7/2021Cholecalciferol Comedication in IBD - the 5C StudyCholecalciferol Comedication in Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C StudyInflammatory Bowel DiseasesDrug: Vitamin D3University Hospital, Basel, SwitzerlandNULLNot yet recruiting18 YearsN/AAll150Phase 3NULL
2NCT05218850
(ClinicalTrials.gov)
July 1, 202220/1/2022The Use of Butyrate Therapy in Pediatric Ulcerative ColitisButyrate Therapy in Pediatric Ulcerative ColitisUlcerative ColitisDrug: ButyrateChildren's Hospital Los AngelesNULLNot yet recruiting7 Years21 YearsAll10Phase 1United States
3NCT05242484
(ClinicalTrials.gov)
May 20, 202215/2/2022A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2b Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeBiological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804Janssen Research & Development, LLCNULLNot yet recruiting18 Years65 YearsAll500Phase 2United States
4NCT05287126
(ClinicalTrials.gov)
April 202210/3/2022A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative ColitisAn Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: EtrasimodArena PharmaceuticalsNULLNot yet recruiting12 Years17 YearsAll36Phase 2NULL
5NCT04314375
(ClinicalTrials.gov)
April 202217/3/2020Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: PlaceboBausch Health Americas, Inc.NULLNot yet recruiting5 Years17 YearsAll70Phase 4NULL
6EUCTR2021-002537-41-ES
(EUCTR)
08/03/202209/03/2022Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
7EUCTR2021-002549-13-NO
(EUCTR)
07/03/202224/11/2021A 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 ColitisA 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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United 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
8EUCTR2018-002378-30-HU
(EUCTR)
01/03/202215/12/2021OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITISOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN 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: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: XELJANZ
Product Name: Tofacitinib citrate
Product Code: CP-690,550-10
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden
9NCT05176366
(ClinicalTrials.gov)
March 1, 202217/11/2021Study of ExoFlo for the Treatment of Medically Refractory Ulcerative ColitisA Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Ulcerative ColitisUlcerative ColitisDrug: ExoFloDirect Biologics, LLCNULLNot yet recruiting18 Years75 YearsAll10Phase 1NULL
10NCT05239702
(ClinicalTrials.gov)
February 28, 20221/12/2021Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune DiseasesA Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune DiseasesCrohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune DiseasesBiological: CD7 CAR T-cellsZhejiang UniversityYake Biotechnology Ltd.RecruitingN/AN/AAll75Early Phase 1China
11EUCTR2021-004398-30-SI
(EUCTR)
24/02/202202/02/2022Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis.A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
203Phase 2Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany
12EUCTR2021-002549-13-HR
(EUCTR)
24/02/202228/02/2022A 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 ColitisA 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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;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
13EUCTR2020-000311-71-FR
(EUCTR)
11/02/202217/09/2021Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onsetPilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Microbiote fécalAP-HP/DRCDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France
14NCT05118919
(ClinicalTrials.gov)
February 9, 202226/10/2021A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative ColitisA Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative ColitisUlcerative ColitisBiological: BGP-014;Biological: PlaceboBioGaia Pharma ABNULLRecruiting18 YearsN/AAll50Phase 1/Phase 2Sweden
15NCT05186623
(ClinicalTrials.gov)
February 5, 202222/12/2021Prediction Model for Response to Biologics and Small Molecular Agent for UCEstablishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal DataUlcerative ColitisDrug: Vedolizumab, Ustekinumab, or TofacitinibAsan Medical CenterNULLRecruiting18 Years79 YearsAll300Korea, Republic of
16EUCTR2021-001644-10-HU
(EUCTR)
04/02/202215/12/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
17EUCTR2021-002537-41-BG
(EUCTR)
02/02/202219/01/2022Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Czechia;Taiwan;Finland;Spain;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden
18NCT05119140
(ClinicalTrials.gov)
February 202220/10/2021HCQ for Non Europeans With Mild to Severe UCAdministration of Hydroxychloroquine (Plaquenil) to Individuals of Non-European Ancestry for the Treatment of Mild to Severe Ulcerative Colitis.Ulcerative Colitis (Disorder)Drug: Hydroxychloroquine;Drug: MesalamineIcahn School of Medicine at Mount SinaiCrohn's and Colitis FoundationRecruiting18 YearsN/AAll20Phase 1/Phase 2United States
19NCT05117749
(ClinicalTrials.gov)
February 202221/10/2021Saffron and Ulcerative ColitisThe Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical TrialUlcerative ColitisDrug: Saffron 100;Drug: Saffron 50;Drug: PlaceboShiraz University of Medical SciencesNULLNot yet recruiting18 Years80 YearsAll60Phase 2NULL
20NCT04987307
(ClinicalTrials.gov)
January 31, 202226/7/2021Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Efavaleukin alfa;Drug: PlaceboAmgenNULLRecruiting18 Years80 YearsAll320Phase 2United States;Austria;Bulgaria;Japan;Korea, Republic of;Poland
21EUCTR2021-003050-23-LT
(EUCTR)
25/01/202211/10/2021VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects 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]
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Oppilan Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany
22NCT04804540
(ClinicalTrials.gov)
January 10, 202215/3/2021A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's DiseaseA Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn DiseaseDrug: Vedolizumab IVTakedaNULLNot yet recruiting18 Years65 YearsAll150Phase 4NULL
23EUCTR2021-003050-23-PL
(EUCTR)
02/01/202229/09/2021VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects 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]
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002
Oppilan Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany
24NCT04924270
(ClinicalTrials.gov)
January 20227/6/2021Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory DiseasesSafety 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 TrialRheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative ColitisBiological: Faecal microbiota transplantation;Other: PlaceboTorkell EllingsenRegion of Southern Denmark;University of Southern DenmarkNot yet recruiting18 Years70 YearsAll200Phase 2NULL
25NCT05121402
(ClinicalTrials.gov)
December 30, 20215/11/2021Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative ColitisA PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TLL018 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative ColitisDrug: TLL018;Other: PlaceboHangzhou Highlightll Pharmaceutical Co., LtdTLL Pharmaceutical, LLCNot yet recruiting18 Years75 YearsAll100Phase 2NULL
26JPRN-jRCT1051210145
28/12/202128/12/2021Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trialEfficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial ulcerative colitis
ulcerative colitis;D003093
Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeksooi makotoNULLRecruiting>= 18age old<= 80age oldBoth150Phase 3Japan
27JPRN-jRCT2011210047
22/12/202129/10/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis - EXPEDITION OLE Ulcerative ColitisCompleters in the lead-in study will receive a maintenance dose of brazikumab 240 mg
administered SC every 4 weeks (Group A). The 240 mg SC dose of brazikumab will be
administered to all responders/completers in the lead-in study regardless of the prior treatment
administered. Participants in the lead-in study who have not responded to treatment and have
met criteria for rescue treatment are considered inadequate/non-responders (Group B). In
these eligible participants, IV induction dosing with 1440 mg of brazikumab at Week 0, Week
4, and Week 8 will be administered, followed by brazikumab 240 mg SC-administered every 4
weeks thereafter (up to Week 52).
Hibi KazushigeNULLPending>= 18age old<= 80age oldBoth21Phase 2India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan
28EUCTR2021-001644-10-IT
(EUCTR)
21/12/202117/09/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
29EUCTR2021-002537-41-DE
(EUCTR)
15/12/202113/10/2021Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden
30EUCTR2021-004398-30-SK
(EUCTR)
14/12/202127/10/2021A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
203Phase 2Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany
31EUCTR2021-002537-41-NL
(EUCTR)
08/12/202113/10/2021Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
32EUCTR2021-001280-24-LT
(EUCTR)
07/12/202119/08/2021Study of VE202 in Patients with Ulcerative ColitisRandomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis Mild-to-moderate 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: VE202
Product Code: VE202
INN or Proposed INN: Not applicable
Other descriptive name: JNJ-72537634
Vedanta Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czechia;Hungary;Poland;Ukraine;Lithuania;Russian Federation;Netherlands;United States
33EUCTR2021-002537-41-HU
(EUCTR)
06/12/202125/10/2021Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Czechia;Taiwan;Finland;Korea, Democratic People's Republic of;Ukraine;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
34NCT05177835
(ClinicalTrials.gov)
December 3, 202115/12/2021Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative ColitisA Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 25 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative ColitisUlcerative ColitisDrug: ABX464Abivax S.A.NULLRecruiting18 YearsN/AAll203Phase 2Belgium;Czechia;Hungary;Poland
35EUCTR2021-002549-13-LT
(EUCTR)
02/12/202106/09/2021A 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 ColitisA 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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;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
36EUCTR2021-002549-13-SK
(EUCTR)
02/12/202124/08/2021A 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 ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;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
37EUCTR2021-004398-30-HU
(EUCTR)
01/12/202108/10/2021Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis.A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
203Phase 2Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany
38NCT05112263
(ClinicalTrials.gov)
December 1, 202126/10/2021Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative ColitisTofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized StudyUlcerative ColitisDrug: Tofacitinib;Drug: CyclosporinePostgraduate Institute of Medical Education and ResearchAll India Institute of Medical Sciences, New DelhiNot yet recruiting18 Years65 YearsAll96N/ANULL
39EUCTR2021-001644-10-ES
(EUCTR)
30/11/202112/08/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
40NCT05084261
(ClinicalTrials.gov)
November 30, 202120/9/2021An 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 ColitisDrug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: BT051 up to 3200 mg;Drug: Matching PlaceboBacainn Therapeutics, Inc.NULLRecruiting18 Years75 YearsAll44Phase 1United States;Georgia;Moldova, Republic of;Poland;Ukraine
41NCT05156125
(ClinicalTrials.gov)
November 30, 20211/12/2021VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: VTX002;Drug: PlaceboOppilan Pharma LtdNULLRecruiting18 Years80 YearsAll180Phase 2United States;Czechia;Georgia;Hungary;Poland;Ukraine
42EUCTR2021-004398-30-IT
(EUCTR)
29/11/202101/10/2021Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis.A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - Long-term safety and efficacy follow-up of ABX464 in 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 Name: ABX464
Product Code: [ABX464]
INN or Proposed INN: ABX464
AbivaxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
203Phase 2Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany
43NCT04985968
(ClinicalTrials.gov)
November 24, 202122/7/2021The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: Cobitolimod 250 mg;Drug: Cobitolimod 500 mg;Drug: PlaceboInDex PharmaceuticalsNULLRecruiting18 YearsN/AAll440Phase 3Hungary
44EUCTR2021-002549-13-IT
(EUCTR)
22/11/202119/10/2021A 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 ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;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
45EUCTR2018-001605-93-HU
(EUCTR)
22/11/202105/05/2020Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United 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
46EUCTR2021-003050-23-HU
(EUCTR)
22/11/202101/10/2021VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects 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]
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Oppilan Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany
47EUCTR2020-001811-26-BE
(EUCTR)
18/11/202122/07/2021IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Belgium;Netherlands
48EUCTR2020-004355-33-CZ
(EUCTR)
18/11/202101/07/2021First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative ColitisRandomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate 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: MH002
Product Code: MH002
MRM Health NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 1;Phase 2Czech Republic;Belgium
49EUCTR2021-000091-11-IT
(EUCTR)
08/11/202102/09/2021A study of efficacy of PRA023 in patients with Ulcerative ColitisA 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 - ARTEMIS-UC Study Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: PRA023
Product Code: [PRA023]
Other descriptive name: PRA023
Prometheus Biosciences Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia;Bulgaria
50NCT05181137
(ClinicalTrials.gov)
November 5, 202110/12/2021A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative ColitisA Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: SHR0302;Drug: PlaceboReistone Biopharma Company LimitedNULLRecruiting18 Years75 YearsAll368Phase 3United States;China;Georgia;Poland;Ukraine
51NCT04855799
(ClinicalTrials.gov)
November 2, 202120/4/2021GI Permeability Change in Response to Aquamin®Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®Ulcerative Colitis;Healthy;Irritable Bowel Syndrome With DiarrheaDrug: AquaminJames VaraniNULLRecruiting18 Years80 YearsAll30Phase 2United States
52NCT04276740
(ClinicalTrials.gov)
November 1, 202112/2/2020MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative ColitisMitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UCUlcerative Colitis FlareDietary Supplement: MitoQ;Other: PlaceboUniversity of EdinburghJP Moulton Charitable Foundation;MitoQNot yet recruiting18 YearsN/AAll206Phase 2NULL
53NCT05088369
(ClinicalTrials.gov)
November 202112/10/2021Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201A 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 DiseaseDrug: HM201;Drug: PlaceboSyneos HealthHimuka AM Pharma Corp.Not yet recruiting18 Years55 YearsAll68Early Phase 1NULL
54NCT04626947
(ClinicalTrials.gov)
October 30, 202129/9/2020Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease;C. Diff. InfectionsBiological: BezlotoxumabDavid Binion, MDMerck Sharp & Dohme Corp.Recruiting18 YearsN/AAll50Phase 4United States
55NCT05076175
(ClinicalTrials.gov)
October 29, 20214/10/2021A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative ColitisA Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional TherapyColitis, UlcerativeDrug: OzanimodBristol-Myers SquibbNULLNot yet recruiting2 Years17 YearsAll120Phase 2/Phase 3United States;France;Japan
56EUCTR2020-004457-76-PL
(EUCTR)
28/10/202115/09/2021A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions.A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis
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
MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3France;United States;Argentina;Poland;Turkey;Russian Federation;Japan
57JPRN-jRCT2041200098
28/10/202102/02/2021A 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 KazukoNULLRecruiting>= 2age old< 18age oldBoth90Phase 3United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan
58EUCTR2021-003050-23-CZ
(EUCTR)
25/10/202118/08/2021VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects 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]
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Product Code: VTX002
INN or Proposed INN: not yet available
Other descriptive name: VTX002 is not biologic
Oppilan Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Hungary;Poland;Georgia;Germany
59NCT04499495
(ClinicalTrials.gov)
October 25, 202131/7/2020Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in KoreaA Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in KoreaUlcerative ColitisOther: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)Ferring PharmaceuticalsNULLRecruiting15 YearsN/AAll15000Korea, Republic of
60EUCTR2021-002537-41-IT
(EUCTR)
21/10/202126/01/2022Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. - - Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: [AMG 592]
INN or Proposed INN: EFAVALEUKIN ALFA
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden
61EUCTR2021-000091-11-CZ
(EUCTR)
20/10/202122/04/2021A study of PRA023 in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Georgia
62EUCTR2021-002549-13-DE
(EUCTR)
20/10/202128/06/2021A 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 ColitisA 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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Spain;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
63NCT04779307
(ClinicalTrials.gov)
October 19, 20211/3/2021A 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 TherapyColitis, UlcerativeDrug: VedolizumabTakedaNULLRecruiting2 Years17 YearsAll120Phase 3United States
64JPRN-jRCT2071210030
19/10/202131/05/2021A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative ColitisA 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, UlcerativeInduction 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 MitsuhiroNULLRecruiting>= 2age old<= 17age oldBoth120Phase 3United 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
65NCT05061446
(ClinicalTrials.gov)
October 16, 202120/9/2021Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLRecruiting20 Years80 YearsAll96Phase 2Japan
66NCT04924114
(ClinicalTrials.gov)
October 14, 202126/2/2021A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: MK-6194;Drug: MK-6194-matching placeboMerck Sharp & Dohme Corp.NULLRecruiting18 Years80 YearsAll30Phase 1United States;Georgia;Germany;Moldova, Republic of;Ukraine;United Kingdom
67EUCTR2021-001280-24-HU
(EUCTR)
13/10/202118/08/2021Study of VE202 in Patients with Ulcerative ColitisRandomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis Mild-to-moderate 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: VE202
Product Code: VE202
INN or Proposed INN: Not applicable
Other descriptive name: JNJ-72537634
Vedanta Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Czechia;Hungary;Poland;Ukraine;Lithuania;Russian Federation;Netherlands
68EUCTR2020-004300-34-IT
(EUCTR)
13/10/202130/08/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
69NCT04999228
(ClinicalTrials.gov)
October 1, 20215/8/2021Top Down Versus Step up in Pediatric Ulcerative ColitisFirst-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative ColitisUlcerative Colitis;Infliximab;ChildrenDrug: Infliximab;Drug: CorticosteroidsChildren's Hospital of Fudan UniversityNULLNot yet recruiting6 Years18 YearsAll40Phase 4NULL
70NCT05058417
(ClinicalTrials.gov)
October 1, 202116/9/2021Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative ColitisAssessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative ColitisUlcerative ColitisDrug: Placebo;Drug: Empagliflozin 10 MGSadat City UniversityNULLRecruiting18 Years60 YearsAll50Phase 2Egypt
71NCT03843385
(ClinicalTrials.gov)
October 202114/2/2019Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitisLongterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitisUlcerative Colitis;Inflammatory Bowel DiseasesDrug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: PlaceboJena University HospitalGerman Federal Ministry of Education and ResearchNot yet recruiting18 Years75 YearsAll174Phase 2/Phase 3NULL
72NCT04857112
(ClinicalTrials.gov)
September 29, 202119/4/2021Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative ColitisA Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)Ulcerative ColitisDrug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: PlaceboBausch Health Americas, Inc.NULLRecruiting18 Years75 YearsAll336Phase 2United States
73NCT04767984
(ClinicalTrials.gov)
September 24, 202123/2/2021Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative ColitisA Randomized and Placebo-Controlled Phase II Trial Targeting Dominant-Negative Missense Mutant P53 by Atorvastatin for Reducing the Risk of Longstanding Ulcerative Colitis-Associated CancerColorectal Carcinoma;Ulcerative ColitisDrug: Atorvastatin Calcium;Procedure: Biospecimen Collection;Drug: Placebo AdministrationNational Cancer Institute (NCI)NULLRecruiting18 Years70 YearsAll70Phase 2United States
74EUCTR2021-002549-13-HU
(EUCTR)
24/09/202123/07/2021A 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 ColitisA 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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;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
75EUCTR2020-004355-33-BE
(EUCTR)
23/09/202108/06/2021First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative ColitisRandomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate 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: MH002
Product Code: MH002
MRM Health NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 1;Phase 2Belgium
76EUCTR2019-002485-12-IT
(EUCTR)
23/09/202122/10/2020Determination of the Optimal Treatment Target in Ulcerative ColitisVERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT 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
Product Name: Entyvio
Product Code: [NA]
Other descriptive name: VEDULIZUMAB
Trade Name: Entyvio
Product Name: Entyvio
Product Code: [NA]
Other descriptive name: VEDOLIZUMAB
ALIMENTIV INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 4United States;France;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy
77JPRN-jRCTs031210326
21/09/202121/09/2021Evaluation of biomarkers in BF treatmentA 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 drugMatsuoka KatsuyoshiEA Pharma Co., Ltd.Recruiting>= 16age oldNot applicableBoth20N/AJapan
78EUCTR2020-004300-34-SK
(EUCTR)
18/09/202128/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
79JPRN-jRCT2051210087
17/09/202122/09/2021Safety and pharmacokinetics study in healthy Japanese volunteersA 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 colitisPart 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 YasukoNULLPending>= 20age old<= 45age oldMale48Phase 1Japan
80EUCTR2020-004461-40-IT
(EUCTR)
15/09/202118/10/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC)
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 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: [BMS-986165]
INN or Proposed INN: deucravacitinib
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
81JPRN-jRCT2011210030
14/09/202130/08/2021Phase 2 Dose-finding UC StudyA 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 KazushigeNULLRecruiting>= 18age old<= 80age oldBoth21Phase 2India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan
82EUCTR2021-000091-11-HU
(EUCTR)
13/09/202117/04/2021A study of PRA023 in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Georgia
83EUCTR2021-001940-86-PL
(EUCTR)
11/09/202109/08/2021A phase 3 Study to Evaluate the Efficacy and Safety of SHR0302 in Ulcerative Colitis.A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 for Induction, Maintenance Therapy 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: SHR0302 tablets
Product Code: SHR0302
INN or Proposed INN: SHR0302
Reistone Biopharma Company LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Poland;Ukraine;Georgia;China
84NCT05030064
(ClinicalTrials.gov)
September 10, 20219/8/2021Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With DepressionClinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With DepressionUlcerative ColitisDrug: Intestinal flora capsule;Procedure: placebo capsuleThird Military Medical UniversityNULLRecruiting18 Years65 YearsAll54N/AChina
85EUCTR2021-002549-13-SE
(EUCTR)
07/09/202116/06/2021A 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 ColitisA 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 PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;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
86NCT04979832
(ClinicalTrials.gov)
September 6, 202130/6/2021GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA SurgeryA Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis SurgeryPouchitisDrug: GM-CSF, fosfomycin and metronidazoleZealand University HospitalNULLRecruiting18 YearsN/AAll18Phase 1/Phase 2Denmark
87EUCTR2018-003524-36-NO
(EUCTR)
06/09/202116/06/2021Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE 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: Remicade
Trade Name: Metoject
Trade Name: Puri-Nethol
Trade Name: Remsima
Trade Name: Inflectra
UMC Amsterdam location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 4France;Ireland;Netherlands;Norway;United Kingdom
88EUCTR2021-003023-14-SE
(EUCTR)
02/09/202123/06/2021Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative ColitisPharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis Moderate to Severe 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 Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Sweden
89NCT03935451
(ClinicalTrials.gov)
September 1, 202123/4/2019Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel DiseaseA Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot StudyIBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal DisordersDrug: Apixaban 2.5 milligram;Drug: Placebo Oral TabletMcMaster UniversityNULLRecruiting18 YearsN/AAll60Early Phase 1Canada
90NCT05019742
(ClinicalTrials.gov)
September 202113/8/2021Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative ColitisA Double-Blind, Placebo-Controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SPH3127 in Patients With Mild-to-Moderate Ulcerative ColitisUlcerative ColitisDrug: SPH3127;Drug: PlaceboShanghai Pharma Biotherapeutics USA Inc.NULLRecruiting18 Years70 YearsAll30Phase 2United States
91JPRN-jRCT2071210052
23/08/202119/08/2021Etrasimod Dose-Ranging Versus Placebo as Induction Therapy inModerately to Severely Active Ulcerative ColitisA 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 colitisEligible 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 weeksTanabe MasakazuNULLRecruiting>= 20age old<= 80age oldBoth96Phase 2Japan
92EUCTR2020-004300-34-HR
(EUCTR)
18/08/202102/09/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
93EUCTR2020-005232-30-SK
(EUCTR)
17/08/202109/06/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) 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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2United States;Serbia;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Georgia;Bulgaria;Germany;Japan;Moldova, Republic of;Korea, Republic of
94JPRN-jRCT2031210210
16/08/202128/07/2021A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's DiseaseA master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ Ulcerative Colitis / Crohn's Disease
-
Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Yoshimoto YusukeNULLRecruitingNot applicableNot applicableBoth5Phase 3United States;Japan
95EUCTR2021-002211-65-ES
(EUCTR)
13/08/202111/06/2021EFFECT OF TOFACITINIB ON COAGULATIONEFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Level: PT;Classification code 10009790;Term: Coagulation time;System Organ Class: 10022891 - Investigations
MedDRA version: 21.0;Classification code 10061684;Term: Platelet function test;System Organ Class: 10022891 - Investigations;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: Tofacitinib
INN or Proposed INN: TOFACITINIB
Fundación Española de GastroenterologíaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Spain
96JPRN-jRCT2071210075
12/08/202107/10/2021Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative ColitisOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS Ulcerative ColitisDrug: tofacitinib
Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID.
Kawai NorisukeNULLRecruiting>= 2age old<= 17age oldBoth120Phase 3Australia;Canada;United States;Japan
97NCT04624230
(ClinicalTrials.gov)
August 12, 202126/10/2020Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative ColitisOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITISUlcerative ColitisDrug: tofacitinibPfizerNULLRecruiting2 Years17 YearsAll120Phase 3United States;Australia;Canada;Israel;Japan;Poland;Spain
98EUCTR2020-003420-16-ES
(EUCTR)
11/08/202123/06/2021A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT 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]
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Amgevita
Instituto Clinico HumanitasNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 4Portugal;France;Belgium;Spain;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
99EUCTR2020-004300-34-HU
(EUCTR)
06/08/202128/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
100EUCTR2021-000091-11-PL
(EUCTR)
06/08/202120/05/2021A study of PRA023 in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Czechia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia
101EUCTR2020-005232-30-DE
(EUCTR)
05/08/202129/04/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) 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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2United States;Serbia;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;New Zealand;Moldova, Republic of;Japan;Korea, Republic of
102EUCTR2020-004461-40-DE
(EUCTR)
04/08/202112/05/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC)
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 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: BMS-986165
INN or Proposed INN: deucravacitinib
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Germany;Japan;Romania;Poland;Brazil;Belgium;Canada;Mexico;Hungary;United Kingdom;Czechia;Korea, Republic of;China;Netherlands;Denmark;Australia;France;Switzerland;Italy;Israel;Russian Federation;Ireland;Spain;Taiwan;Portugal;United States
103NCT04933162
(ClinicalTrials.gov)
August 3, 202115/6/2021UC Cohort - The Influence of Diet on Gut MicrobiotasUC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut MicrobiotasUlcerative ColitisDietary Supplement: High Protein and Low Fiber Diet;Dietary Supplement: Low Protein and High Fiber DietMayo ClinicNULLRecruiting18 YearsN/AAll70N/AUnited States
104NCT04898348
(ClinicalTrials.gov)
August 202113/5/2021A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative ColitisA Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative ColitisUlcerative ColitisDrug: Vancomycin Pre-Treatment;Drug: KBL697;Drug: PlaceboKoBioLabsNULLNot yet recruiting18 Years75 YearsAll30Phase 2NULL
105EUCTR2020-005232-30-EE
(EUCTR)
27/07/202126/04/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) 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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of
106NCT04963725
(ClinicalTrials.gov)
July 18, 20218/7/2021A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical PracticeSymptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported OutcomesUlcerative ColitisDrug: UstekinumabJanssen Pharmaceutical K.K.NULLRecruiting16 YearsN/AAll140Japan
107EUCTR2018-002135-19-FR
(EUCTR)
16/07/202102/04/2019A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United 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
108EUCTR2020-003420-16-BE
(EUCTR)
16/07/202130/06/2021A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitisSPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT 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]
Trade Name: Amgevita
INN or Proposed INN: Adalimumab 40mg
Trade Name: Azathioprine
Other descriptive name: AZATHIOPRINE BP
Instituto Clinico HumanitasNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 4Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
109ChiCTR2100048502
2021-07-152021-07-09Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled TrialsModified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials Ulcerative ColitisExperimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNULLPending1875BothExperimental group:3;Control group:3;N/AChina
110NCT04996797
(ClinicalTrials.gov)
July 14, 20212/8/2021A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: PRA023 IV;Device: Companion Diagnostic (CDx) Testing;Other: PlaceboPrometheus Biosciences, Inc.NULLRecruiting18 YearsN/AAll170Phase 2United States
111ChiCTR2100048176
2021-07-122021-07-04A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission periodA randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period Ulcerative colitisExperimental group:Xuyan Decoction;Control group:Mesalazine sustained-release granules;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineNULLPending1865BothExperimental group:44;Control group:44;China
112EUCTR2019-004578-25-SE
(EUCTR)
09/07/202127/12/2019A clinical study in patients with mild to moderate ulcerative colitis to test the tolerability of Lactobacillus reuteri BGP-014A randomised placebo-controlled safety study of Lactobacillus reuteri BGP-014 in patients with active mild to moderate ulcerative colitis Mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: BGP-014 Capsules
Product Code: BGP-014
INN or Proposed INN: Lactobacillus reuteri
Other descriptive name: LACTOBACILLUS REUTERI
BioGaia Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 1;Phase 2Sweden
113EUCTR2020-000609-10-DK
(EUCTR)
06/07/202123/09/2020A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patientsA 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 ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 1;Phase 2Denmark
114ChiCTR2100046446
2021-07-012021-05-15Effect of probiotics supplementation combined with WeChat platform health management on nutritional status, inflammatory factors, and quality of life in patients with mild-to-moderate ulcerative colitisEffect of probiotics supplementation combined with WeChat platform health management on nutritional status, inflammatory factors, and quality of life in patients with mild-to-moderate ulcerative colitis ulcerative colitisexperimental group:Bifidobacterium triple live bacteria combined with WeChat platform for health management intervention;control group:Mesalazine Oral;Affiliated Hospital of Jiangnan UniversityNULLRecruiting1880Bothexperimental group:70;control group:70;N/AChina
115NCT04828031
(ClinicalTrials.gov)
July 1, 202129/3/2021Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel DiseaseVitamin D Regulation of a4ß7+ B Cell Immunophenotypes and Mucosal Antibody Response to Commensal Gut Bacteria in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDrug: Vitamin DStanford UniversityDoris Duke Charitable FoundationRecruiting18 YearsN/AAll50Phase 1United States
116NCT04968951
(ClinicalTrials.gov)
July 20219/7/2021Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)REFOCUS: Refined Fecal Microbiota Transplantation (FMT) Delivered by Oral Capsules for Induction of Remission in Mild to Moderate Ulcerative Colitis - a Phase I StudyUlcerative Colitis;FMT;Fecal Microbiota TransplantDrug: Metronidazole;Drug: Placebo;Drug: Vancomycin;Biological: Fecal Microbiota TransplantationAri M GrinspanNULLRecruiting18 Years75 YearsAll20Early Phase 1United States
117EUCTR2019-003113-34-SK
(EUCTR)
29/06/202127/04/2021Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany
118EUCTR2020-004300-34-LT
(EUCTR)
25/06/202121/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
119NCT04372108
(ClinicalTrials.gov)
June 24, 202130/4/2020A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative ColitisAn 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 DatabaseCrohn Disease;Colitis, UlcerativeDrug: Ustekinumab;Drug: Other Biologic TherapiesJanssen Scientific Affairs, LLCNULLRecruiting18 YearsN/AAll1056United States
120EUCTR2020-005232-30-BG
(EUCTR)
22/06/202102/06/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) 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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of
121EUCTR2020-005232-30-HU
(EUCTR)
21/06/202123/04/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) 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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of
122NCT04596293
(ClinicalTrials.gov)
June 11, 202115/10/2020A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension PhaseA Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension PhaseUlcerative ColitisDrug: BBT-401-1S;Drug: PlaceboBridge Biotherapeutics, Inc.CovanceRecruiting18 Years60 YearsAll36Phase 2United States;Korea, Republic of;New Zealand;Poland;Ukraine
123JPRN-jRCT2031200371
04/06/202119/02/2021A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseAn Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who Experienced Secondary Loss of Response During Maintenance Therapy with Vedolizumab IV Administered Every 8 Weeks (Q8W) Ulcerative Colitis, Crohn's DiseaseVedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase.Shikamura MitsuhiroNULLRecruiting>= 18age old<= 80age oldBoth158Phase 3Japan
124NCT04738942
(ClinicalTrials.gov)
June 4, 20212/2/2021A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseAn Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)Ulcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaNULLRecruiting18 Years80 YearsAll158Phase 3Japan
125EUCTR2020-004300-34-ES
(EUCTR)
02/06/202101/09/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
126EUCTR2020-004300-34-GR
(EUCTR)
01/06/202129/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United 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
127NCT04882683
(ClinicalTrials.gov)
June 1, 20216/5/2021Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative ColitisClinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative ColitisUlcerative ColitisDrug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cellsShandong Qilu Stem Cells Engineering Co., Ltd.NULLRecruiting18 Years65 YearsAll50N/AChina
128NCT04925973
(ClinicalTrials.gov)
June 1, 20218/6/2021Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis ManagementTofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management (the TRIUMPH Study)Ulcerative Colitis AcuteDrug: Tofacitinib 10 MG [Xeljanz]McMaster UniversityUniversity of Manitoba;University of British Columbia;McGill University;University of AlbertaRecruiting18 YearsN/AAll26Phase 2Canada
129NCT04919252
(ClinicalTrials.gov)
June 1, 20216/4/2021Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel DiseaseEfficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel DiseaseCrohn's Disease and Ulcerative ColitisDrug: VedolizumabYonsei UniversityNULLNot yet recruiting19 Years70 YearsAll60Phase 3Korea, Republic of
130NCT04478825
(ClinicalTrials.gov)
June 1, 202116/7/2020Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative ColitisAn Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative ColitisUlcerative ColitisDrug: BBT-401-1SBridge Biotherapeutics, Inc.CovanceTerminated18 Years60 YearsAll2Phase 1New Zealand
131NCT04617184
(ClinicalTrials.gov)
June 1, 20212/11/2020Registry and Biorepository for IBD in Central TexasRegistry and Biorepository for the Study of Inflammatory Bowel Diseases in Central TexasCrohn Disease;Ulcerative Colitis;Inflammatory Bowel DiseasesOther: NO INTERVENTIONUniversity of Texas at AustinNULLRecruiting18 Years100 YearsAll1000United States
132NCT04908644
(ClinicalTrials.gov)
June 202125/5/2021MS-20 on Patients With Ulcerative Colitis(UC)Study to Evaluate Efficacy and Safety of MS 20 on Patients With Ulcerative ColitisUlcerative ColitisDrug: MS-20 oral solution;Other: PlaceboNational Taiwan University HospitalMicrobio Co LtdNot yet recruiting20 Years65 YearsAll40N/ANULL
133EUCTR2018-004002-25-SK
(EUCTR)
28/05/202113/01/2021A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand;Sweden
134EUCTR2018-004002-25-LV
(EUCTR)
27/05/202102/02/2021A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 2;Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan;Sweden
135EUCTR2020-003017-35-SK
(EUCTR)
26/05/202128/12/2020A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-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: LY3471851
Product Code: LY3471851
INN or Proposed INN: LY3471851
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of
136NCT04844606
(ClinicalTrials.gov)
May 26, 202112/4/2021A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Crohn's DiseaseDrug: MirikizumabEli Lilly and CompanyNULLRecruiting2 Years19 YearsAll185Phase 3United States;Israel;Japan;Korea, Republic of
137NCT04879966
(ClinicalTrials.gov)
May 17, 20216/5/2021A Cohort Study Comparing IFX to CS for Moderate to Severe UCA Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisDrug: Infliximab;Drug: CorticosteroidSixth Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting18 Years70 YearsAll342China
138NCT04898530
(ClinicalTrials.gov)
May 15, 202113/5/2021Diet Patterns in IBD in Central TexasA Cross-sectional Assessment of Diet in Patients With IBD in Central TexasInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisOther: NO INTERVENTIONUniversity of Texas at AustinNULLRecruiting18 YearsN/AAll500United States
139NCT04877990
(ClinicalTrials.gov)
May 7, 20214/5/2021A Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative ColitisCrohn Disease;Ulcerative ColitisDrug: BMS-986165Bristol-Myers SquibbNULLRecruiting18 YearsN/AAll300Phase 2United States;Australia;Brazil;China;Germany;Hungary;Italy;Japan;Poland;Romania;Russian Federation;United Kingdom
140ChiCTR2100046284
2021-05-062021-05-12Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis ulcerative colitisControl group:Prednisone+Azathioprine/Adalimumab;Test group:Prednisone+Azathioprine/Adalimumab+umbilical cord blood mononuclear cells;The Second Affiliated Hospital of Shandong University of Traditional Chinese MedicineNULLRecruiting1865BothControl group:25;Test group:25;China
141EUCTR2019-002485-12-PL
(EUCTR)
05/05/202122/09/2020Determination of the Optimal Treatment Target in Ulcerative ColitisVERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT 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: VEDOLIZUMAB
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Alimentiv Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 4France;United States;Belarus;Canada;Belgium;Poland;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy
142NCT04862741
(ClinicalTrials.gov)
May 5, 202110/3/2021Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative ColitisA Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative ColitisUlcerative ColitisDrug: NX-13 250mg IR;Drug: NX-13 500mg IR;Drug: NX-13 500mg MR;Drug: PlaceboLandos Biopharma Inc.NULLActive, not recruiting18 Years65 YearsAll40Phase 1United States;Ukraine
143NCT04231110
(ClinicalTrials.gov)
May 1, 20212/1/2020Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative ColitisCombination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative ColitisUlcerative ColitisBiological: Fecal microbiota transplantationMcMaster UniversityNULLRecruiting18 YearsN/AAll10Phase 4Canada
144EUCTR2019-002485-12-NL
(EUCTR)
23/04/202103/08/2020Determination of the Optimal Treatment Target in Ulcerative ColitisVERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT 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: VEDOLIZUMAB
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Alimentiv Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 4France;United States;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy
145NCT04064697
(ClinicalTrials.gov)
April 22, 202120/8/2019Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab TherapyImpact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy.Ulcerative Colitis, UnspecifiedDrug: ValganciclovirCentre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruiting18 YearsN/AAll120Phase 3France
146NCT04469062
(ClinicalTrials.gov)
April 20, 202110/7/2020A Study of Mirikizumab (LY3074828) in Participants With Ulcerative ColitisA Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SCEli Lilly and CompanyNULLWithdrawn18 Years80 YearsAll0Phase 3NULL
147NCT04607837
(ClinicalTrials.gov)
April 19, 202123/10/2020Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLRecruiting18 Years80 YearsAll162Phase 2United States;Australia;Belarus;Belgium;Bulgaria;Canada;Czechia;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Portugal;Russian Federation;Spain;Ukraine
148EUCTR2020-003556-33-PL
(EUCTR)
19/04/202117/02/2021A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative ColitisA Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase Moderate to severe 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: BBT-401-1S
Product Code: BBT-401-1S
INN or Proposed INN: None
Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate
Bridge Biotherapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Poland;Ukraine;New Zealand;Korea, Republic of
149EUCTR2020-003017-35-BE
(EUCTR)
15/04/202105/02/2021A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-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: LY3471851
Product Code: LY3471851
INN or Proposed INN: LY3471851
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of
150JPRN-jRCTs011200009
08/04/202106/11/2020vedolizumab-4026A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026 Subjects with UCVedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration is 46 weeks.Fujiya MikihiroTakeda Pharmaceutical Company Limited (Takeda)Recruiting>= 20age old<= 80age oldBoth30Phase 4Japan
151EUCTR2020-003507-34-BG
(EUCTR)
02/04/202110/02/2021Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162Phase 2Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of
152NCT04818788
(ClinicalTrials.gov)
April 1, 202120/3/2021Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative ColitisHematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological TherapyUlcerative ColitisDrug: Biological DrugAssiut UniversityNULLNot yet recruiting18 Years55 YearsAll24NULL
153NCT04677179
(ClinicalTrials.gov)
March 22, 20218/12/2020A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: LY3471851;Drug: PlaceboEli Lilly and CompanyNektar TherapeuticsRecruiting18 Years75 YearsAll200Phase 2United States;Argentina;Australia;Belgium;Brazil;Canada;China;Czechia;France;Georgia;Hungary;India;Israel;Japan;Korea, Republic of;Latvia;Poland;Romania;Russian Federation;Slovakia;Ukraine;United Kingdom;Germany
154NCT04630028
(ClinicalTrials.gov)
March 17, 202113/11/2020A 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 ColitisColitis, UlcerativeDrug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching PlaceboJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll90Phase 3United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom
155NCT04613518
(ClinicalTrials.gov)
March 15, 202128/10/2020A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative ColitisColitis, UlcerativeDrug: BMS-986165 Dose 1;Drug: BMS-986165 Dose 2;Other: Placebo ComparatorBristol-Myers SquibbNULLRecruiting18 Years65 YearsAll50Phase 2United States;Australia;Canada;Germany;Netherlands;Poland;Puerto Rico;United Kingdom
156EUCTR2020-000047-31-PL
(EUCTR)
13/03/202115/07/2021A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 2Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Moldova, Republic of
157EUCTR2019-002942-19-DK
(EUCTR)
12/03/202105/11/2020Nordic study of treatment strategy in inflammatory bowel diseaseNORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile Crohn's disease and Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Trade Name: Puri-nethol
INN or Proposed INN: MERCAPTOPURINE
Region Örebro länNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 4Denmark
158EUCTR2019-003334-16-BG
(EUCTR)
11/03/202102/12/2020Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitisRandomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis acute 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: Budenofalk® suppositories
INN or Proposed INN: BUDESONIDE
Other descriptive name: Budenofalk® suppositories (BUS)
Trade Name: Salofalk 3g gastro-resistant prolonged-release granules
Product Name: Salofalk 3g gastro-resistant prolonged-release granules
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
159EUCTR2016-004676-22-FR
(EUCTR)
09/03/202126/01/2021A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative ColitisA 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. KGNULLNot RecruitingFemale: yes
Male: yes
942Phase 3Portugal;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
160EUCTR2020-003017-35-CZ
(EUCTR)
04/03/202129/12/2020A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-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: LY3471851
Product Code: LY3471851
INN or Proposed INN: LY3471851
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;Japan;China;Korea, Republic of
161EUCTR2019-001653-99-BE
(EUCTR)
26/02/202126/02/2021A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitisA Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT 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: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Trade Name: Entyvio
Product Name: vedolizumab
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Portugal;Serbia;United States;Slovakia
162EUCTR2020-003507-34-PT
(EUCTR)
26/02/202104/01/2021Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162Phase 2United States;Portugal;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of
163EUCTR2019-004224-38-DE
(EUCTR)
25/02/202120/10/2020A 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 ColitisA 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
164EUCTR2020-002833-13-PL
(EUCTR)
24/02/202119/11/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Poland;Ukraine;Georgia;Netherlands
165EUCTR2016-004677-40-FR
(EUCTR)
23/02/202124/12/2020A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative ColitisA 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 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-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1547Phase 2;Phase 3Portugal;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;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
166NCT04691232
(ClinicalTrials.gov)
February 22, 20217/12/2020Autologous Ex Vivo Expanded Regulatory T Cells in Ulcerative ColitisPhase I, Open-label, Fast-track Dose-escalation Clinical Trial Exploring the Safety and the Tolerability of Autologous ex Vivo Expanded Regulatory T Cells in Adults With Ulcerative ColitisUlcerative Colitis;Autoimmune DiseasesBiological: Regulatory T cellsUniversity of Erlangen-Nürnberg Medical SchoolNULLRecruiting18 Years18 YearsAll10Phase 1Germany
167EUCTR2020-003017-35-HU
(EUCTR)
17/02/202129/12/2020A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-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: LY3471851
Product Code: LY3471851
INN or Proposed INN: LY3471851
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of
168EUCTR2020-003507-34-HU
(EUCTR)
11/02/202129/12/2020Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162Phase 2Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
169EUCTR2020-000047-31-DE
(EUCTR)
11/02/202117/08/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 2Belarus;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
170EUCTR2019-004878-26-NL
(EUCTR)
10/02/202120/10/2020A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. Moderate to Severe Ulcerative Colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Australia;Germany;Netherlands;United Kingdom
171EUCTR2020-003507-34-IT
(EUCTR)
09/02/202130/08/2021Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162Phase 2Portugal;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
172EUCTR2020-003006-31-IT
(EUCTR)
08/02/202102/08/2021Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritisPredictive 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 CUORENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Italy
173NCT04750135
(ClinicalTrials.gov)
February 7, 20217/2/2021Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative ColitisAssessment of Metformin as Adjuvant Therapy in Patients With Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseasesDrug: metformin 500 mg TID Oral Tablet;Drug: PlaceboNational Hepatology & Tropical Medicine Research InstituteNULLNot yet recruiting18 Years65 YearsAll40Phase 2Egypt
174EUCTR2020-002833-13-NL
(EUCTR)
05/02/202129/10/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Poland;Ukraine;Georgia;Netherlands
175EUCTR2020-003507-34-FR
(EUCTR)
02/02/202116/12/2020Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162Phase 2United 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
176JPRN-UMIN000043165
2021/02/0131/01/2021Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel diseaseSafety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease Crohn's disease, Ulcerative colitis, IBDUwitching from originator infliximab to infliximab biosimilar CT-P13Fukuoka University Chikushi HospitalNULLPendingNot applicableNot applicableMale and Female220Not selectedJapan
177EUCTR2019-001653-99-LT
(EUCTR)
01/02/202123/09/2020A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitisA Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT 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: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Trade Name: Entyvio
Product Name: vedolizumab
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland
178EUCTR2020-003420-16-IT
(EUCTR)
29/01/202102/08/2021A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.” - SPRINT Moderate to severe 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]
Trade Name: Amgevita
Product Name: Adalimumab
Product Code: [n.d.]
INN or Proposed INN: ADALIMUMAB
Product Name: Azatioprina
Product Code: [n.d.]
INN or Proposed INN: AZATIOPRINA
Product Name: Prednisone
Product Code: [n.d.]
INN or Proposed INN: PREDNISONE
INN or Proposed INN: PREDNISONE
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 4Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
179JPRN-jRCT1031200329
28/01/202128/01/2021UC Bio StudyOpen-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness Ulcerative colitis
Biologics;D003093
Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks.
Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks
Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy.
Body weight dose
55kg or less 260mg
55-85kg 390mg
85kg or more 520mg

After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks.
Naganuma MakotoNULLRecruiting>= 16age oldNot applicableBoth231N/AJapan
180EUCTR2019-001653-99-LV
(EUCTR)
18/01/202126/10/2020A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitisA Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT 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: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Trade Name: Entyvio
Product Name: vedolizumab
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
181JPRN-jRCT2071200081
12/01/202113/01/2021ELEVATE UC OLE: An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitisEtrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant s country, whichever comes firstIQVIA Services Japan K.K. ICCC:NULLNot Recruiting>= 16age old<= 80age oldBoth35Phase 3Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Croatia;Czech Republic;Denmark;Egypt;Estonia;France;Germany;Hungary;India;Israel;Italy;Korea;Lebanon;Mexico;Moldova;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Japan
182EUCTR2020-002306-12-PL
(EUCTR)
12/01/202108/09/2020GB004 in adult subjects with active ulcerative colitisA Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate GB004 in adult subjects with mild-to-moderate active ulcerative colitis Mild-to-moderate active 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 Code: GB004
INN or Proposed INN: Not applicable
Other descriptive name: GB004-HCl
Product Code: GB004
INN or Proposed INN: Not applicable
Other descriptive name: GB004-HCl
GB004, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Poland;Ukraine;Romania;Australia;Russian Federation;Georgia;Italy;Moldova, Republic of;Korea, Republic of
183EUCTR2019-001653-99-DE
(EUCTR)
08/01/202105/10/2020A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitisA Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT 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: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
184EUCTR2019-004878-26-DE
(EUCTR)
05/01/202124/08/2020A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. Moderate to Severe Ulcerative Colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Australia;Netherlands;Germany;United Kingdom
185EUCTR2019-004224-38-HU
(EUCTR)
30/12/202022/10/2020A 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 ColitisA 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
186JPRN-jRCT2071200080
25/12/202013/01/2021ELEVATE UC 40 JAPAN: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Japanese SubjectsA 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 colitisThe investigational drug and the placebo are an oral tablet. The investigational drug is APD334 (etrasimod).IQVIA Services Japan K.K. ICCC:NULLNot Recruiting>= 16age old<= 80age oldBoth35Phase 3Japan
187NCT04706793
(ClinicalTrials.gov)
December 25, 202011/1/2021A 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 ColitisA 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 ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLActive, not recruiting16 Years80 YearsAll42Phase 3Japan
188NCT04721873
(ClinicalTrials.gov)
December 18, 202019/1/2021Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese PatientsPharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled TrialColitis, Ulcerative;ObesityDrug: Phentermine-Topiramate;Drug: PlaceboUniversity of California, San DiegoNULLRecruiting18 Years80 YearsAll40Phase 2United States
189EUCTR2020-001398-59-BE
(EUCTR)
15/12/202013/10/2020Clinical 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: Lusvertikimab
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127
OSE ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Serbia;Belarus;Hungary;Poland;Belgium;Ukraine;Lithuania;Croatia;Russian Federation;Georgia;Bulgaria;Latvia
190NCT04749576
(ClinicalTrials.gov)
December 15, 20209/12/2020Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel DiseaseEfficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel DiseaseUlcerative ColitisDietary Supplement: saffron supplement for IBDHoward UniversityNULLRecruiting18 Years80 YearsAll100N/AUnited States
191NCT04469686
(ClinicalTrials.gov)
December 10, 20202/7/2020Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative ColitisUlcerative ProctitisCombination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicatorCristcot LLCCristcot HCA LLCRecruiting18 YearsN/AAll618Phase 3United States;Germany;Hong Kong;India;Italy;Philippines;Poland;Romania;Russian Federation;Spain;Ukraine
192NCT03414788
(ClinicalTrials.gov)
December 7, 20208/1/2018Distribution 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 DiseasePHASE 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 SUBJECTSInflammatory Bowel DiseaseBiological: PF 06687234;Biological: [124I]IB PF 06687234PfizerNULLWithdrawn18 Years75 YearsAll0Phase 1United States
193NCT04424303
(ClinicalTrials.gov)
December 7, 20208/6/2020Tofacitinib in Adult Patients With Moderate to Severe Ulcerative ColitisEvaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst StudyUlcerative ColitisDrug: TofacitinibPfizerNULLRecruiting18 YearsN/AAll280France
194EUCTR2020-001398-59-HR
(EUCTR)
02/12/202007/12/2020Clinical 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 ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
195EUCTR2019-001653-99-FR
(EUCTR)
26/11/202012/10/2020A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitisA Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT 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: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Trade Name: Entyvio
Product Name: vedolizumab
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Malaysia;Denmark;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
196EUCTR2020-000047-31-BG
(EUCTR)
25/11/202008/10/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 2Belarus;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
197NCT04505410
(ClinicalTrials.gov)
November 18, 20205/8/2020Xeljanz and Healthy DietA Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Tofacitinib (Xeljanz) InductionUlcerative ColitisDrug: Tofacitinib;Other: Fast Mimicking DietUniversity of MiamiPfizerRecruiting18 YearsN/AAll76Phase 3United States
198EUCTR2019-002698-74-GB
(EUCTR)
17/11/202030/03/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
199NCT04312113
(ClinicalTrials.gov)
November 16, 202014/3/2020Angiographic Delivery of AD-MSC for Ulcerative ColitisA Phase I Single Site Open Label Study of Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative ColitisUlcerative ColitisDrug: Adipose derived, autologous mesenchymal stem cellsMayo ClinicNULLRecruiting18 Years65 YearsAll20Phase 1United States
200NCT04543994
(ClinicalTrials.gov)
November 10, 20203/9/2020Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative ColitisUlcerative ColitisDrug: Remestemcel-L;Other: PlaceboThe Cleveland ClinicMesoblast, Inc.Recruiting18 Years75 YearsAll24Phase 1/Phase 2United States
201NCT04331639
(ClinicalTrials.gov)
November 1, 202023/3/2020High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic TherapyImplementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or VedolizumabInflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D DeficiencyDietary Supplement: vitamin D3Boston Children's HospitalNULLRecruiting5 Years25 YearsAll50Phase 2United States
202ChiCTR2000039161
2020-10-302020-10-20Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trialA systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility Ulcerative colitiscontrol group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;Chengdu University of Traditional Chinese MedicineNULLRecruiting2045Femalecontrol group:118;experimental group:118;China
203EUCTR2020-004391-18-FR
(EUCTR)
28/10/202014/09/2020IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITISIMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Inflectra 100 mg
Product Name: Inflectra 100 mg
Trade Name: AMGEVITA
Product Name: AMGEVITA
Trade Name: Simponi
Product Name: Simponi
Trade Name: Entyvio 300 mg
Product Name: Entyvio 300 mg
Trade Name: XELJANZ
Product Name: XELJANZ
CHU Amiens-PicardieNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4France
204EUCTR2018-005086-39-BG
(EUCTR)
27/10/202025/06/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
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: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
205NCT04883840
(ClinicalTrials.gov)
October 22, 20206/5/2021Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative ColitisDrug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative ColitisUlcerative ColitisDrug: Rosuvastatin 10mgUniversitaire Ziekenhuizen LeuvenVlaams Instituut Biotechnologie (VIB)Recruiting18 Years70 YearsAll220Phase 2/Phase 3Belgium
206ChiCTR2000038888
2020-10-192020-10-09Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trialA systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility Ulcerative colitiscontrol group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;Chengdu University of Traditional Chinese MedicineNULLRecruiting2045Femalecontrol group:118;experimental group:118;China
207NCT04556383
(ClinicalTrials.gov)
October 19, 202015/9/2020A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative ColitisUlcerative ColitisDrug: GB004;Drug: PlaceboGB004, Inc.NULLActive, not recruiting18 YearsN/AAll195Phase 2United States;Georgia;Korea, Republic of;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Ukraine;Australia
208EUCTR2020-002695-12-NL
(EUCTR)
14/10/202002/09/2020Treatment of refractory pouchitis with tofacitinibTofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis Chronic, recurrent and/or antibiotic refractory pouchitis in patients with 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: Xeljanz 5mg film-coated tabletsAmsterdam UMC, location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Netherlands
209EUCTR2020-001398-59-BG
(EUCTR)
13/10/202018/09/2020Clinical 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: Lusvertikimab
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127
OSE ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;South Africa;Latvia
210EUCTR2020-000047-31-FR
(EUCTR)
07/10/202013/05/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 2United 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
211NCT04577794
(ClinicalTrials.gov)
October 5, 202030/9/2020A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: GLPG3970;Drug: PlaceboGalapagos NVNULLCompleted18 Years64 YearsAll31Phase 2Georgia;Moldova, Republic of;Poland;Ukraine
212NCT04882007
(ClinicalTrials.gov)
October 2, 202013/4/2021Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative ColitisRandomized, 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)Ulcerative ColitisDrug: OSE-127;Drug: PlaceboOSE ImmunotherapeuticsNULLRecruiting18 Years75 YearsAll150Phase 2Belarus;Belgium;Bulgaria;Croatia;Georgia;Hungary;Latvia;Poland;Russian Federation;South Africa;Ukraine
213ChiCTR2000037261
2020-10-012020-08-27Study on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironmentStudy on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironment Ulcerative Colitisexperimental group:stasis removing and immunoregulation therapy;control group:mesalamine;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, ShanghaiNULLRecruiting1865Bothexperimental group:30;control group:30;China
214ChiCTR2000036950
2020-10-012020-08-25Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat TypeStudy of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type Uicerative colitisJianpi Huashi Decoction Group:Jianpi Huashi Decoction;Mesalazine Group:Mesalazine;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCMNULLRecruitingBothJianpi Huashi Decoction Group:45;Mesalazine Group:45;China
215ChiCTR2000037220
2020-10-012020-08-27A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitisA randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis ulcerative colitisTraditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules;Shuguang Hospital affiliated to Shanghai University of traditional Chinese MedicineNULLRecruitingBothTraditional Chinese medicine group:40;Western medicine group:40;China
216JPRN-UMIN000041972
2020/10/0101/10/2020Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis.Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. - BS-UC-2020 ulcerative colitisBroccoli Sprouts (20 g/day, 8 weeks)
Alfalfa Sprouts (20 g/day, 8 weeks)
University of TsukubaNULLRecruiting20years-oldNot applicableMale and Female50Not selectedJapan
217ChiCTR2000035497
2020-10-012020-08-13A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitisA multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis ulcerative colitisExperimental group:Qingyusan;Control group:Mesalazine;Shuguang Hospital affiliated to Shanghai University of traditional Chinese MedicineNULLPendingBothExperimental group:40;Control group:40;China
218NCT04225819
(ClinicalTrials.gov)
October 1, 20203/1/2020Adjunctive Treatment With Vitamin D3 in Patients With Active IBDAdjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled TrialIBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 DeficiencyDietary Supplement: Vitamin D3;Other: PlaceboMassachusetts General HospitalNULLRecruiting18 YearsN/AAll100N/AUnited States
219NCT04535882
(ClinicalTrials.gov)
October 1, 202028/8/2020Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBDAssociation Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease ColitisLRG LevelsDiagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levelsShowa Inan General HospitalNULLRecruitingN/AN/AAll125Japan
220EUCTR2020-001811-26-NL
(EUCTR)
30/09/202008/07/2020IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Netherlands
221EUCTR2020-001398-59-LV
(EUCTR)
21/09/202028/07/2020Clinical 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
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127
OSE ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
222NCT04223518
(ClinicalTrials.gov)
September 20, 20206/1/2020Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel DiseaseInflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: PlaceboMonisha Hitesh ShahNULLRecruiting6 Years30 YearsAll43Early Phase 1United States
223NCT04259138
(ClinicalTrials.gov)
September 17, 20204/2/2020Determination of the Optimal Treatment Target in Ulcerative ColitisVERDICT: In actiVE Ulcerative Colitis, a RanDomIzed Controlled Trial for Determination of the Optimal Treatment TargetColitis, UlcerativeBiological: Treatment Algorithm A;Biological: Treatment Algorithm B;Biological: Treatment Algorithm CAlimentiv Inc.Takeda Development Center Americas, Inc.Recruiting18 YearsN/AAll660Phase 4United States;Belgium;Canada;France;Netherlands;Poland;Ukraine;United Kingdom
224NCT04353791
(ClinicalTrials.gov)
September 16, 202024/3/2020Study of OST-122 in Patients With Moderate to Severe Ulcerative ColitisA Phase Ib/IIa, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Treatment With OST-122 in Patients With Moderate to Severe Ulcerative ColitisUlcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic SevereDrug: OST-122;Drug: PlaceboOncostellae S.LNULLRecruiting18 Years75 YearsAll32Phase 1/Phase 2Spain
225NCT03996369
(ClinicalTrials.gov)
September 15, 202021/6/2019Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLCompleted16 Years80 YearsAll354Phase 3United 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
226NCT04373473
(ClinicalTrials.gov)
September 14, 202028/4/2020Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative ColitisA Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative ColitisAdults With Ulcerative ColitisDrug: PRIM-DJ2727;Drug: PlacebosThe University of Texas Health Science Center, HoustonNULLRecruiting18 YearsN/AAll58Phase 2United States
227NCT04338204
(ClinicalTrials.gov)
September 14, 20204/4/2020Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In SwedenObservational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN)Ulcerative ColitisDrug: tofacitinibPfizerNULLRecruiting18 Years99 YearsAll120Sweden
228EUCTR2020-000659-11-PL
(EUCTR)
10/09/202023/07/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with ulcerative colitisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Poland;Ukraine;Georgia;Moldova, Republic of
229EUCTR2020-000047-31-HU
(EUCTR)
09/09/202007/07/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 2Belarus;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
230EUCTR2019-002698-74-DE
(EUCTR)
08/09/202021/02/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;South Africa;Germany;China;Japan
231NCT04205643
(ClinicalTrials.gov)
September 2, 202018/12/2019CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative ColitisA 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 ColitisUlcerative ColitisBiological: CT-P13 SC (Infliximab);Other: Placebo SCCelltrionNULLActive, not recruiting18 Years75 YearsAll548Phase 3Poland
232NCT04348890
(ClinicalTrials.gov)
September 1, 202013/4/2020Proof of Concept Trial of Vamorolone in Pediatric Ulcerative ColitisA Phase I/II Open-Label, Proof-of-Concept Study of Vamorolone in Children and Adolescents With Mild-Moderately Active Ulcerative ColitisPediatric Ulcerative ColitisDrug: Vamorolone 4% suspension for oral dosingReveraGen BioPharma, Inc.NULLWithdrawn4 Years17 YearsAll0Phase 1/Phase 2NULL
233JPRN-jRCTs031200103
01/09/202001/09/2020Alginate combined fecal microbiota transplantation for ulcerative colitisSingle 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 DaiNULLRecruiting>= 20age oldNot applicableBoth60N/AJapan
234ChiCTR2000032498
2020-09-012020-04-30Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis: a randomized double-blind controlled trialHuman experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis Ulcerative colitisExperimental group:Probiotics and prebiotics;placebo group:maltodextrin;Capital Medical UniversityNULLPendingBothExperimental group:15;placebo group:15;China
235NCT04521205
(ClinicalTrials.gov)
September 202018/8/2020A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseA Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseInflammatory Bowel Disease, Ulcerative Colitis TypeDrug: fecal microbiota capsuleZhongshan Hospital Xiamen UniversityNULLRecruiting18 Years65 YearsAll200Phase 1China
236EUCTR2019-004652-11-SI
(EUCTR)
28/08/202031/08/2020A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative ColitisRANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana 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: Etrolizumab
Product Code: RO5490261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany
237NCT04583358
(ClinicalTrials.gov)
August 26, 202016/9/2020Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)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 (LOMBARD)Ulcerative ColitisDrug: AMT-101 (oral);Other: Placebo (oral)Applied Molecular TransportNULLRecruiting18 Years80 YearsAll102Phase 2United States;Bulgaria;Canada;France;Georgia;Germany;Hungary;Moldova, Republic of;Poland;Russian Federation;Switzerland;Ukraine;United Kingdom
238NCT04576000
(ClinicalTrials.gov)
August 25, 202017/9/2020Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative ColitisPhaRmacOkinetics and PHarmacodynamic BiomarkErs of Janus Kinase Inhibitor Therapy in PatIents With Ulcerative Colitis (PROPHETIC)Ulcerative ColitisDrug: Janus Kinase InhibitorAlimentiv Inc.Alimentiv Translational Research ConsortiumRecruiting18 YearsN/AAll40United States;Belgium;Canada;Italy;Netherlands;Spain
239EUCTR2018-000930-37-HU
(EUCTR)
17/08/202024/06/2020A 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 TherapyA 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
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
240EUCTR2019-003999-39-NO
(EUCTR)
17/08/202029/04/2020A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitisA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH 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: PF-06826647
Product Code: PF-06826647
INN or Proposed INN: PF-06826647
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
202Phase 2United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway
241JPRN-UMIN000042017
2020/08/1305/10/2020Hydrogen gas inhalation randomized double blinded trial for ulcerative colitisHydrogen gas inhalation randomized double blinded trial for ulcerative colitis - Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis Ulcerative colitishydrogen gas
8 weeks inhalation
the inhalation for 4 hours per day
12 weeks observation after the inhalation
placebo gas
8 weeks inhalation
the inhalation for 4 hours per day
12 weeks observation after the inhalation
Juntendo University HospitalNULLRecruiting20years-oldNot applicableMale and Female20Not selectedJapan
242EUCTR2019-004469-41-DE
(EUCTR)
11/08/202026/03/2020A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
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: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943
Protagonist Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
169Phase 2Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
243EUCTR2019-004469-41-BG
(EUCTR)
11/08/202027/04/2020A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
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: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943
Protagonist Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
169Phase 2Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
244NCT04504383
(ClinicalTrials.gov)
August 5, 20205/8/2020PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative ColitisUlcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic SevereDrug: PN-943;Drug: PlaceboProtagonist Therapeutics, Inc.NULLActive, not recruiting18 Years75 YearsAll150Phase 2United States;Austria;Bulgaria;Canada;Georgia;Germany;Hungary;Italy;Korea, Republic of;Poland;Russian Federation;Serbia;Ukraine
245EUCTR2020-000047-31-GB
(EUCTR)
03/08/202020/04/2020A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 2Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of
246EUCTR2019-004208-37-BE
(EUCTR)
03/08/202004/03/2020Statins for treating ulcerative colitis through GI microbiomeDrug 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 LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Belgium
247ChiCTR2000035099
2020-08-012020-07-31Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technologyStudy on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology Uicerative colitisulcerative colitis damp-heat syndrome group:nil;ulcerative colitis qi deficiency syndrome group:nil;healthy control group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;damp-heat syndrome control group:Mesalazine;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;qi deficiency syndrome control group:Mesalazine;Jiangsu Province Hospital of Chinese MedicineNULLRecruiting1865Bothulcerative colitis damp-heat syndrome group:30;ulcerative colitis qi deficiency syndrome group:30;healthy control group:30;damp-heat syndrome treatment group:60;damp-heat syndrome control group:30;qi deficiency syndrome treatment group:60;qi deficiency sChina
248EUCTR2019-003596-19-DE
(EUCTR)
29/07/202029/07/2020A 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
618Phase 3United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India
249EUCTR2019-004469-41-AT
(EUCTR)
27/07/202026/03/2020A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
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: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943
Protagonist Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
250NCT03920254
(ClinicalTrials.gov)
July 23, 202028/3/2019TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) StudyA 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)Ulcerative Colitis (UC)Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose CTheravance BiopharmaNULLTerminated18 YearsN/AAll46Phase 2/Phase 3United States;Australia;Bulgaria;Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine
251EUCTR2019-002485-12-GB
(EUCTR)
14/07/202030/03/2020Determination of the Optimal Treatment Target in Ulcerative ColitisVERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT 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: VEDOLIZUMAB
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Alimentiv Inc. (formerly Robarts Clinical Trials)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 4France;Belarus;United States;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;Italy;United Kingdom
252NCT04458805
(ClinicalTrials.gov)
July 10, 202016/6/2020Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female VolunteersA Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female VolunteersUlcerative ColitisDrug: NX-13 250 mg;Drug: PlaceboLandos Biopharma Inc.NULLCompleted18 Years64 YearsAll56Phase 1Australia
253EUCTR2018-004002-25-NL
(EUCTR)
06/07/202017/09/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden
254EUCTR2018-004694-27-FR
(EUCTR)
06/07/202010/04/2020Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 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] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Poland;Australia;Germany;Japan;Korea, Republic of;United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium
255EUCTR2018-003986-33-PT
(EUCTR)
06/07/202028/10/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Phase 3Ukraine;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
256EUCTR2019-004469-41-IT
(EUCTR)
02/07/202015/06/2021A trial to investigate the safety and efficacy of PN-943 in patients withmoderate or severe Ulcerative Colitis (a long-term condition where thecolon and rectum become inflamed)A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis - PN-943-03 Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
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: PN-943
Product Code: [PN-943]
INN or Proposed INN: ACETATO DI AMMONIO
Other descriptive name: PN-943
Product Name: PN-943
Product Code: [PN-943]
INN or Proposed INN: ACETATO DI AMMONIO
Protagonist Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of
257EUCTR2017-004092-31-AT
(EUCTR)
02/07/202020/09/2019A study of the efficacy and safety of Mirikizumab in Ulcerative ColitisI6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 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: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
960Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
258NCT04360343
(ClinicalTrials.gov)
July 1, 20206/4/2020Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy SubjectsA Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy SubjectsUlcerative ColitisDrug: Film-coated tabletLG ChemNULLCompleted19 Years45 YearsAll18Phase 1Korea, Republic of
259ChiCTR2000033953
2020-07-012020-06-18Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) Ulcerative colitisPlacebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059;Jiangnan UniversityNULLPendingBothPlacebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20;China
260NCT04457960
(ClinicalTrials.gov)
July 1, 20201/7/2020A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative ColitisA 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-66525433Healthy;Colitis, UlcerativeDrug: JNJ-66525433;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 Years60 YearsAll140Phase 1Georgia;Germany;Moldova, Republic of
261NCT04209556
(ClinicalTrials.gov)
June 30, 20201/12/2019A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative ColitisA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative ColitisDrug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QDPfizerNULLRecruiting18 Years75 YearsAll202Phase 2United States
262EUCTR2019-003334-16-DE
(EUCTR)
26/06/202005/05/2020Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitisRandomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis acute 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: Budenofalk® suppositories
INN or Proposed INN: BUDESONIDE
Other descriptive name: Budenofalk® suppositories (BUS)
Trade Name: Salofalk 3g gastro-resistant prolonged-release granules
Product Name: Salofalk 3g gastro-resistant prolonged-release granules
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
263EUCTR2019-003596-19-IT
(EUCTR)
26/06/202017/06/2021A 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
618Phase 3United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Russian Federation;Germany;Italy;India
264EUCTR2019-001430-33-DE
(EUCTR)
18/06/202025/02/2020A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitisA Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: GS-4875
Product Code: GS-4875
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2Canada;Belgium;Poland;Australia;Germany;United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic
265NCT04188990
(ClinicalTrials.gov)
June 15, 20202/12/2019Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related MalnutritionEvaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related MalnutritionPancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal CancerDietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current careHospital Galdakao-UsansoloNULLActive, not recruiting18 YearsN/AAll900N/ASpain
266EUCTR2018-003987-29-FR
(EUCTR)
11/06/202012/09/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Phase 3Lebanon;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;Ukraine;Spain;Thailand;Slovakia;Estonia;Taiwan;Belarus;Portugal;Serbia;United States;Bulgaria;Georgia;Germany;Japan
267EUCTR2019-003849-15-HR
(EUCTR)
05/06/202020/11/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3United 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
268EUCTR2019-002698-74-BE
(EUCTR)
03/06/202002/04/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
269NCT03802214
(ClinicalTrials.gov)
June 1, 202010/12/2018Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF(Tumor Necrosis Factor)TherapyA Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab TherapyUlcerative ColitisDrug: VedolizumabStanford UniversityTakeda;University of Western Ontario, Canada;University of California, San DiegoRecruiting18 YearsN/AAll20United States;Canada
270NCT04259060
(ClinicalTrials.gov)
June 202027/1/2020Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis ResearchHydroxocobalamin Approach to Reduction of Nitrite With Butyrate for Ulcerative ColitisUlcerative ColitisDrug: Hydroxocobalamin with Butyrate;Drug: Placebo with ButyrateJoshua KorzenikNULLNot yet recruiting18 Years75 YearsAll42Phase 2United States
271EUCTR2019-003849-15-CZ
(EUCTR)
28/05/202016/03/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3Belarus;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
272JPRN-JapicCTI-194980
22/5/202030/09/2019A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 ColitisIntervention 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.NULLrecruiting18BOTH1000Phase 2-3Japan, Asia except Japan, North America, Europe
273EUCTR2019-001430-33-PL
(EUCTR)
20/05/202028/02/2020A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitisA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: GS-4875
Product Code: GS-4875
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany
274EUCTR2019-002698-74-IT
(EUCTR)
20/05/202015/06/2021A study to evaluate the efficacy and safety of PF-06480605 in adult participants with moderate to severe ulcerative colitis.A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS. - TUSCANY 2 A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY IN ADULT WITH MODERATE TO SEVERE ULCERATIVE COLITIS.
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: [PF-06480605]
INN or Proposed INN: PF-06480605
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;China;Japan
275EUCTR2018-001605-93-DE
(EUCTR)
20/05/202004/06/2019Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United 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
276EUCTR2019-002698-74-FR
(EUCTR)
20/05/202024/01/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
277NCT04004611
(ClinicalTrials.gov)
May 18, 202029/6/2019A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: MirikizumabEli Lilly and CompanyNULLRecruiting2 Years17 YearsAll30Phase 2United States;Canada;Israel;Japan;Korea, Republic of
278EUCTR2019-001430-33-AT
(EUCTR)
15/05/202031/01/2020A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitisA Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: GS-4875
Product Code: GS-4875
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
279NCT04272307
(ClinicalTrials.gov)
May 14, 202014/2/2020MIcroorganisms 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;UlcerativeBiological: Blood samples;Procedure: Stool samples;Procedure: Colorectal biopsiesUniversity Hospital, BordeauxMcGill University Health Centre/Research Institute of the McGill University Health CentreRecruiting18 YearsN/AAll40France
280EUCTR2019-000733-39-FR
(EUCTR)
14/05/202020/02/2020Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands
281EUCTR2018-004002-25-BG
(EUCTR)
13/05/202024/02/2020A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
282EUCTR2019-003849-15-ES
(EUCTR)
12/05/202028/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3United 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
283EUCTR2019-001430-33-IT
(EUCTR)
05/05/202027/01/2021A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitisA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis - FALCON 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: GS-4875
Product Code: [GS-4875]
Product Name: GS-4875
Product Code: [GS-4875]
GILEAD SCIENCES INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czechia;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany
284EUCTR2019-001430-33-GB
(EUCTR)
05/05/202021/02/2020A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitisA Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: GS-4875
INN or Proposed INN: to be confirmed
Product Code: GS-4875
INN or Proposed INN: to be confirmed
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Czechia;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Australia;Germany
285EUCTR2019-003780-21-NL
(EUCTR)
04/05/202021/02/2020Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC 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]
Trade Name: XELJANZ
Product Name: Janus kinase Inhibitor
INN or Proposed INN: Janus kinase Inhibitor
Alimentiv Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4United States;Canada;Spain;Belgium;Netherlands;Italy
286EUCTR2019-003113-34-NO
(EUCTR)
04/05/202021/01/2020Ulcerative colitisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;Czechia;Hungary;Slovakia;Poland;Russian Federation;Bulgaria;Germany;Norway
287NCT04156984
(ClinicalTrials.gov)
May 202024/10/2019Comparison of Two Different Golimumab Dosing Regimens for Ulcerative ColitisExposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose RegimensUlcerative ColitisDrug: Golimumab Prefilled SyringeDavid DrobneNULLNot yet recruiting18 Years65 YearsAll30Phase 4Slovenia
288ChiCTR2000028767
2020-04-272020-01-03A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitisA randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis ulcerative colitisExperimental group:Oseltamivir and mesalazine;Control group:mesalazine;Xiangya Hospital of Central South UniversityNULLRecruiting1875BothExperimental group:53;Control group:53;N/AChina
289EUCTR2018-003278-28-BG
(EUCTR)
22/04/202023/05/2019Safety, 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United 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
290EUCTR2019-000733-39-GB
(EUCTR)
16/04/202031/01/2020Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
291EUCTR2019-003849-15-IT
(EUCTR)
15/04/202017/06/2021Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3Serbia;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
292EUCTR2019-002698-74-HU
(EUCTR)
15/04/202020/04/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
293EUCTR2018-003987-29-AT
(EUCTR)
15/04/202009/10/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLNot RecruitingFemale: yes
Male: yes
912Phase 3Portugal;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;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
294EUCTR2018-003986-33-AT
(EUCTR)
07/04/202020/09/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;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
295EUCTR2017-003703-22-BG
(EUCTR)
07/04/202006/02/2020Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
296EUCTR2018-004002-25-DE
(EUCTR)
07/04/202023/08/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
297EUCTR2019-003849-15-BG
(EUCTR)
03/04/202007/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3Serbia;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
298EUCTR2019-003849-15-FR
(EUCTR)
03/04/202003/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3United 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
299EUCTR2019-003849-15-GR
(EUCTR)
03/04/202002/04/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3United 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
300EUCTR2019-001430-33-FR
(EUCTR)
02/04/202020/02/2020A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitisA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: GS-4875
Product Code: GS-4875
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
301NCT03980405
(ClinicalTrials.gov)
April 1, 20205/6/2019Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative ColitisCombination Therapy With Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative Colitis: A Single Blinded, International Randomized Controlled TrialUlcerative ColitisDietary Supplement: Group 1- Control Diet;Dietary Supplement: Group 2- UCD DietProf. Arie LevineNULLRecruiting10 Years19 YearsAll62N/AIsrael
302NCT04332328
(ClinicalTrials.gov)
April 1, 202031/3/2020Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper EgyptStudy of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper EgyptDiet in Ulcerative Colitis PatientsDietary Supplement: DietAssiut UniversityNULLNot yet recruitingN/AN/AAll50NULL
303EUCTR2019-002698-74-ES
(EUCTR)
01/04/202023/01/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
304NCT04096573
(ClinicalTrials.gov)
April 202018/9/2019Efficacy and Safety of LC51-0255 in Subjects With Ulcerative ColitisA Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: LC51-0255;Drug: PlaceboLG ChemNULLWithdrawn18 Years80 YearsAll0Phase 2NULL
305EUCTR2019-002698-74-BG
(EUCTR)
27/03/202031/01/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
306EUCTR2019-002698-74-SK
(EUCTR)
26/03/202031/01/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605 100 mg/ml
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;China;Japan
307EUCTR2018-003524-36-IE
(EUCTR)
25/03/202005/11/2019Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE 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: Remicade
Product Name: NA
Product Code: NA
INN or Proposed INN: INFLIXIMAB
Trade Name: Metoject
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
UMC Amsterdam location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 4Ireland;Netherlands
308EUCTR2019-002698-74-PL
(EUCTR)
24/03/202011/02/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Belgium;Japan;China;Germany;South Africa;Bulgaria;Australia;Romania;Poland
309EUCTR2019-000733-39-DE
(EUCTR)
20/03/202013/03/2020Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
217Phase 2Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
310EUCTR2019-003849-15-AT
(EUCTR)
20/03/202006/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3Slovakia;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
311EUCTR2016-000642-62-SE
(EUCTR)
18/03/202025/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, 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 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic
312EUCTR2016-000642-62-FR
(EUCTR)
10/03/202030/07/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, 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 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
313EUCTR2018-001605-93-AT
(EUCTR)
09/03/202007/11/2019Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United 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
314NCT04277546
(ClinicalTrials.gov)
March 3, 202018/2/2020Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)Ulcerative ColitisDrug: Brazikumab Maintenance Dose;Drug: Brazikumab Induction DoseAstraZenecaNULLEnrolling by invitation18 Years80 YearsAll165Phase 2United 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
315EUCTR2017-003703-22-PT
(EUCTR)
02/03/202018/12/2019Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
316EUCTR2018-003987-29-PT
(EUCTR)
02/03/202028/10/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Phase 3Germany;Japan;Georgia;United States;Serbia;Belarus;Portugal;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
317NCT02277223
(ClinicalTrials.gov)
March 1, 202025/10/2014Curcumin in Pediatric Ulcerative ColitisCurcumin for Induction and Maintenance Therapy in Pediatric Ulcerative ColitisUlcerative ColitisDietary Supplement: Curcumin;Drug: PlaceboSchneider Children's Medical Center, IsraelNULLWithdrawn6 Years18 YearsAll0Phase 3Israel
318NCT04309058
(ClinicalTrials.gov)
March 202024/2/2020Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene PolymorphismObservation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort StudyUlcerative Colitis;Vitamin D Deficiency;Vitamin D SupplementDrug: Vitamin D dropsSecond Affiliated Hospital of Wenzhou Medical UniversityNULLNot yet recruitingN/AN/AAll100Early Phase 1China
319EUCTR2018-004002-25-ES
(EUCTR)
28/02/202004/09/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkum
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
320EUCTR2018-003986-33-DK
(EUCTR)
28/02/202002/10/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;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
321EUCTR2017-004092-31-RO
(EUCTR)
26/02/202017/03/2022A study of the efficacy and safety of Mirikizumab in Ulcerative ColitisI6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 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: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
840Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
322EUCTR2019-003987-37-SI
(EUCTR)
26/02/202027/11/2019Comparison of Two Different Golimumab Dosing Regimens for Ulcerative ColitisExposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Simponi
Product Name: Simponi
Product Code: CNTO-148
University Medical Centre Ljubljana, Department of gastroenterologyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSlovenia
323EUCTR2019-003220-21-GB
(EUCTR)
26/02/202012/12/2019Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE.Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. - MODULATE Diarrhoea in patients with stable ulcerative colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10066557;Term: Chronic diarrhoea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Amitriptyline
Product Name: Amitriptyline
INN or Proposed INN: Amitriptyline hydrochloride
Product Name: Ondansetron
INN or Proposed INN: Ondansetron hydrochloride dihydrate
Product Name: Loperamide
INN or Proposed INN: loperamide hydrochloride
University of LeedsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
491Phase 2;Phase 3United Kingdom
324EUCTR2019-003113-34-HU
(EUCTR)
25/02/202009/01/2020Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany
325NCT04241029
(ClinicalTrials.gov)
February 25, 202017/1/2020Boosting Biologics in UCBoosting Biologics in Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseasesDietary Supplement: IDOFORM®TravelOslo University HospitalHelse Sor-OstRecruiting18 Years75 YearsAll20Phase 1Norway
326EUCTR2018-003986-33-GB
(EUCTR)
24/02/202017/09/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Phase 3Serbia;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
327EUCTR2019-003113-34-DE
(EUCTR)
19/02/202008/11/2019Ulcerative colitisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Germany;Norway;Czech Republic;Hungary;United States
328EUCTR2018-003987-29-BG
(EUCTR)
17/02/202023/10/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Portugal;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;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
329NCT04254783
(ClinicalTrials.gov)
February 16, 20203/2/2020A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseA Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis (UC);Crohn's DiseaseDrug: Risankizumab;Drug: Cytochrome P450 (CYP) SubstratesAbbVieNULLRecruiting18 Years80 YearsAll20Phase 1United States;Germany;Israel
330EUCTR2018-003986-33-ES
(EUCTR)
14/02/202024/02/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-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): noSerbia;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
331EUCTR2019-000733-39-AT
(EUCTR)
13/02/202014/10/2019Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
217Phase 2Belgium;Poland;Germany;Serbia;Belarus;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada
332EUCTR2018-003558-26-GB
(EUCTR)
11/02/202005/11/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 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
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
333EUCTR2018-003986-33-BG
(EUCTR)
11/02/202023/10/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;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
334EUCTR2019-004090-50-ES
(EUCTR)
07/02/202011/11/2019Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitisA Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis Moderate to severe ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: OST-122
INN or Proposed INN: Not available yet
Other descriptive name: OST-122
Product Name: OST-122
INN or Proposed INN: Not available yet
Other descriptive name: OST-122
ONCOSTELLAE S.L.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
32 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain
335NCT04074590
(ClinicalTrials.gov)
February 3, 202029/8/2019Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative ColitisA 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 ColitisColitis, UlcerativeDrug: LYS006;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years75 YearsAll45Phase 2United States;Bulgaria;Czechia;Germany;Hungary;Norway;Poland;Russian Federation;Slovakia;United Kingdom
336EUCTR2018-004002-25-PT
(EUCTR)
03/02/202006/08/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 2;Phase 3Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
337NCT04202211
(ClinicalTrials.gov)
February 202013/12/2019FMT for Remission of Active Ulcerative Colitis in AdultsA Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseasesBiological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enemaUniversity of British ColumbiaCrohn's and Colitis Canada;Vancouver Island Health AuthorityNot yet recruiting18 YearsN/AAll145Phase 2Canada
338NCT03998488
(ClinicalTrials.gov)
January 31, 202024/6/2019Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative ColitisA Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseasesDrug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk PowderWeill Medical College of Cornell UniversityCrohn's and Colitis FoundationRecruiting18 Years89 YearsAll135Phase 2United States
339EUCTR2018-002135-19-IT
(EUCTR)
30/01/202017/06/2021A 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]
Product Name: TD-1473
Product Code: [TD-1473]
Product Name: TD-1473
Product Code: [TD-1473]
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United 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
340EUCTR2018-004491-35-RO
(EUCTR)
30/01/202018/03/2022A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative ColitisA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
206Phase 2United States;Czechia;Poland;Romania;Germany
341EUCTR2018-003986-33-LV
(EUCTR)
24/01/202001/11/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3United 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
342EUCTR2018-003987-29-DE
(EUCTR)
23/01/202030/09/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Portugal;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;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
343EUCTR2018-003985-15-AT
(EUCTR)
21/01/202008/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;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
344EUCTR2018-003985-15-FR
(EUCTR)
20/01/202012/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
372Phase 3United 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
345NCT04223479
(ClinicalTrials.gov)
January 15, 20206/1/2020Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, JordanEffect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, JordanUlcerative ColitisDrug: Probiotic Formula Capsule;Drug: PlacebosUniversity of JordanNULLRecruiting35 Years65 YearsAll30Phase 2/Phase 3Jordan
346NCT04183608
(ClinicalTrials.gov)
January 14, 202028/10/2019A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating AdalimumabAn Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL TrialUlcerative ColitisDrug: Adalimumab;Diagnostic Test: Calprotectin;Other: e-Monitoring;Other: Therapy EducationGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesAbbVieRecruiting18 Years75 YearsAll238Phase 4France
347EUCTR2018-003986-33-FR
(EUCTR)
14/01/202020/09/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3United 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
348NCT04023396
(ClinicalTrials.gov)
January 13, 20205/7/2019Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative ColitisA Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: ABX464Abivax S.A.NULLActive, not recruiting18 Years75 YearsAll217Phase 2Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
349EUCTR2018-002136-24-IT
(EUCTR)
10/01/202017/06/2021A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA 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]
Product Name: TD-1473
Product Code: [TD-1473]
Product Name: TD-1473
Product Code: [TD-1473]
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
880Phase 2;Phase 3United 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
350EUCTR2019-000733-39-IT
(EUCTR)
08/01/202022/01/2021Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
AbivaxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands
351ChiCTR2000028869
2020-01-032020-01-05phase IIa clinical trial of Colitis SuppositoriesA multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome)Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical UniversityNULLRecruiting1865BothExperimental group:30;The control group:30;Phase 2China
352EUCTR2018-003986-33-LT
(EUCTR)
31/12/201908/10/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;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
353NCT04130919
(ClinicalTrials.gov)
December 20, 201916/10/2019Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative ColitisA Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Tilpisertib;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll19Phase 2United States;Australia;Austria;Canada;France;Germany;Italy;Poland;Switzerland
354EUCTR2018-003987-29-ES
(EUCTR)
20/12/201920/12/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
702 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
355NCT04090411
(ClinicalTrials.gov)
December 19, 201912/9/2019A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative ColitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITISModerate to Severe Ulcerative ColitisDrug: 50 mg;Drug: 450 mg;Drug: 150 mg;Other: 0 mgPfizerNULLActive, not recruiting18 Years75 YearsAll246Phase 2United States;Australia;Belgium;Bulgaria;Colombia;France;Germany;Hungary;India;Italy;Japan;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Thailand;Turkey;Ukraine;United Kingdom;Austria;Canada
356EUCTR2019-003662-40-DE
(EUCTR)
18/12/201922/10/2019Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen
INN or Proposed INN: ADALIMUMAB
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
82Phase 4Germany
357EUCTR2018-005086-39-HR
(EUCTR)
16/12/201917/01/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
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: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
358EUCTR2018-003278-28-NL
(EUCTR)
13/12/201922/07/2019Safety, 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;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
359EUCTR2019-000733-39-ES
(EUCTR)
11/12/201911/11/2019Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-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): noSerbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany
360EUCTR2018-003558-26-FR
(EUCTR)
10/12/201908/02/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. 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
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands
361ChiCTR1900025900
2019-12-012019-09-13Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. Ulcerative colitisExperimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion;Nanjing Hospital of Chinese MedicineNULLPendingBothExperimental group:200;control group:100;Phase 3China
362NCT04133194
(ClinicalTrials.gov)
November 28, 201910/10/2019Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative ColitisAdherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)Ulcerative ColitisDrug: MesalazineFlemming BendtsenNULLRecruiting18 Years60 YearsAll200Phase 4Denmark
363EUCTR2018-000334-35-NO
(EUCTR)
27/11/201912/06/2019BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Norway KSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
364ChiCTR2000029648
2019-11-262020-02-09The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational studyThe dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study Ulcerative ColitisGC treatment:1mg/kg prednison or other GC with same dose;Health Control:NO intervention;Peking Union Medical College HospitalNULLRecruiting1865BothGC treatment:120;Health Control:30;N/AChina
365EUCTR2019-000733-39-SK
(EUCTR)
21/11/201906/09/2019Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
217Phase 2Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
366EUCTR2018-001605-93-CZ
(EUCTR)
21/11/201905/08/2019Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United 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
367EUCTR2019-003068-39-NL
(EUCTR)
20/11/201904/11/2019In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
UMC UtrechtNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Netherlands
368EUCTR2018-003987-29-DK
(EUCTR)
20/11/201902/10/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Portugal;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;China;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
369EUCTR2017-003703-22-HR
(EUCTR)
20/11/201913/01/2020Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Bosnia and Herzegovina;Netherlands;Germany;Bulgaria;Romania;Croatia;Poland;Belgium;United Kingdom;Russian Federation;North Macedonia;Ukraine;Spain;Czechia;Portugal;Belarus;Serbia;United States
370EUCTR2018-003987-29-LT
(EUCTR)
14/11/201906/11/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Portugal;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;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
371EUCTR2019-000733-39-SI
(EUCTR)
11/11/201916/10/2019Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany
372EUCTR2019-000733-39-PL
(EUCTR)
09/11/201912/09/2019Open-label maintenance therapy in moderate to severe Ulcerative Colitis patientsA 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
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
232Phase 2Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany
373EUCTR2018-003986-33-HR
(EUCTR)
08/11/201917/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3United 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
374EUCTR2018-003987-29-HU
(EUCTR)
07/11/201917/09/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;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;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
375EUCTR2018-003987-29-LV
(EUCTR)
07/11/201916/09/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Phase 3Moldova, Republic of;China;Korea, Republic of;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Latvia;Netherlands;South Africa;Denmark;Australia;France;India;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Lebanon;Ukraine;Spain;Thailand;Slovakia;Taiwan;Estonia;Belarus;United States;Portugal;Serbia;Lithuania;Turkey;Austria;United Kingdom
376EUCTR2018-003986-33-HU
(EUCTR)
07/11/201908/11/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3United 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
377EUCTR2016-000642-62-DE
(EUCTR)
04/11/201918/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, 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 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
522Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Belarus;Serbia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
378NCT05225545
(ClinicalTrials.gov)
November 4, 20199/10/2020Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative ColitisRandomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative ColitisAnemia, Iron Deficiency;Ulcerative ColitisDrug: Sucrosomial Iron;Drug: Oral IronAmerican University of Beirut Medical CenterPharma MRecruiting18 YearsN/AAll30Phase 3Lebanon
379EUCTR2018-000334-35-HU
(EUCTR)
31/10/201906/09/2019BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH&Co. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Norway;Netherlands;Germany;Japan;Korea, Republic of;Denmark;Australia;Belgium;Poland;Canada;Czech Republic;Hungary;Italy;United Kingdom;Russian Federation;Austria;Spain;Greece;United States
380EUCTR2018-003349-41-DE
(EUCTR)
30/10/201919/12/2018Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis 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]
Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Sublimity Therapeutics (Hold Co) Ltd.NULLNot RecruitingFemale: yes
Male: yes
380Phase 2Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany;Ukraine;United States;Serbia;Belarus
381EUCTR2018-002135-19-BG
(EUCTR)
30/10/201911/07/2019A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Japan;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
382EUCTR2018-003558-26-DE
(EUCTR)
30/10/201915/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. 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
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands
383EUCTR2018-005086-39-HU
(EUCTR)
28/10/201908/04/2019A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
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 Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
384EUCTR2018-003278-28-HU
(EUCTR)
24/10/201925/03/2019Safety, 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United 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
385EUCTR2018-004002-25-IT
(EUCTR)
24/10/201917/06/2021A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.4 Solution for infusion in pre-filled syringe
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.4 Solution for infusion in pre-filled syringe
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: Guselkumab
Other descriptive name: * D.3.4 Solution for injection/infusion in pre-filled syringe
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.4 Solution for injection in pre-filled syringe
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3United States;Bulgaria;Germany;Japan;Sweden;Poland;Belgium;Argentina;Canada;Hungary;United Kingdom;Turkey;Czechia;Korea, Republic of;China;Netherlands;Latvia;Australia;Malaysia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Slovakia;Hong Kong;Taiwan;Portugal
386EUCTR2018-003986-33-IT
(EUCTR)
23/10/201922/01/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Phase 3Portugal;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
387EUCTR2018-004002-25-BE
(EUCTR)
21/10/201910/09/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden
388EUCTR2018-003985-15-ES
(EUCTR)
21/10/201921/10/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Serbia;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
389EUCTR2018-004002-25-FR
(EUCTR)
15/10/201914/08/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkum
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
390EUCTR2018-003987-29-IT
(EUCTR)
15/10/201922/01/2021An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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]
Other descriptive name: etrasimod L-arginine
ARENA PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Phase 3India;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;Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy
391NCT03914261
(ClinicalTrials.gov)
October 15, 201911/4/2019Expanded Access to RisankizumabExpanded Access to RisankizumabCrohn's Disease;Ulcerative Colitis (UC)Drug: RisankizumabAbbVieNULLAvailable18 YearsN/AAllBelgium;Israel;Spain;Switzerland;United States
392EUCTR2018-004002-25-SE
(EUCTR)
15/10/201903/07/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
393EUCTR2018-003986-33-BE
(EUCTR)
14/10/201915/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;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
394EUCTR2018-003985-15-PT
(EUCTR)
14/10/201910/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Belarus;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
395EUCTR2018-001605-93-RO
(EUCTR)
10/10/201915/03/2022An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
900Phase 2United 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
396NCT04131322
(ClinicalTrials.gov)
October 10, 201910/10/2019Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH StudyCrohn Disease;Ulcerative ColitisDrug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for InjectionFundación Pública Andaluza para la gestión de la Investigación en SevillaNULLTerminated18 YearsN/AAll24Phase 4Spain
397EUCTR2018-004002-25-GB
(EUCTR)
09/10/201920/08/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 2;Phase 3Germany;Japan;Sweden;Bulgaria;Romania;Poland;Belgium;Brazil;Argentina;Canada;Hungary;Czech Republic;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Taiwan;Portugal;United States
398EUCTR2018-004890-28-IT
(EUCTR)
09/10/201907/10/2020Study for the research of predictive factors of response to Tofacitinib therapy in patients with ulcerative rectal colitis.(A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study). - AVATAR Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xeljanz
Product Name: Xeljanz
Product Code: [N/A]
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Italy
399EUCTR2018-001605-93-BG
(EUCTR)
09/10/201920/09/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United 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
400EUCTR2018-005086-39-PL
(EUCTR)
07/10/201906/05/2019A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
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: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
401EUCTR2018-003987-29-NL
(EUCTR)
07/10/201922/08/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Phase 3Portugal;Belarus;Serbia;United States;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
402EUCTR2017-004230-28-CZ
(EUCTR)
04/10/201911/07/2019BI 655130 induction treatment in patients with moderate-to severe ulcerative colitisA Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Korea, Republic of;China;Japan;Germany;Netherlands;Norway;Denmark;Australia;Belgium;Poland;Argentina;Canada;Mexico;Hungary;Czech Republic;Italy;United Kingdom;Israel;Russian Federation;Austria;Spain;Greece;Taiwan;United States
403EUCTR2018-003986-33-NL
(EUCTR)
03/10/201922/08/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;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
404EUCTR2018-003985-15-IT
(EUCTR)
02/10/201922/01/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Portugal;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
405EUCTR2018-003987-29-HR
(EUCTR)
02/10/201920/01/2020An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
406EUCTR2018-004002-25-HU
(EUCTR)
01/10/201913/08/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 - QUASAR 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: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBulgaria;Germany;Japan;Sweden;Belgium;Poland;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;Malaysia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Thailand;Hong Kong;Taiwan;United States;Portugal
407NCT04006977
(ClinicalTrials.gov)
October 20191/7/2019Multistrain Probiotics Reduces UC Depression and Anxiety ScoresMultistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative ColitisUlcerative ColitisDietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: PlaceboXijing Hospital of Digestive DiseasesMENDES SANot yet recruiting18 Years65 YearsAll60N/AChina
408NCT04102852
(ClinicalTrials.gov)
September 30, 201917/9/2019Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC PatientsThe Role of Lactobacillus Rhamnosus GG (ATCC 53103) in the Modulation of the Inflammatory Process in the Mucosa of Ulcerative Colitis (UC) Patients With Mild-moderate Clinical ActivityUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDietary Supplement: Lactobacillus rhamnosus GG ATCC 53103San Giovanni Addolorata HospitalOnlus S. AndreaRecruiting18 Years65 YearsAll80Phase 1/Phase 2Italy
409EUCTR2018-003490-10-FR
(EUCTR)
30/09/201926/09/2019 An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial - CONTROL 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: HUMIRA
INN or Proposed INN: ADALIMUMAB
GETAIDNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
238 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance
410EUCTR2018-003985-15-BG
(EUCTR)
27/09/201912/08/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United 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
411EUCTR2018-003985-15-DK
(EUCTR)
27/09/201924/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;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
412NCT04033445
(ClinicalTrials.gov)
September 26, 201924/7/2019A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: Placebo;Drug: GuselkumabJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll1000Phase 2/Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania
413EUCTR2018-001605-93-IT
(EUCTR)
26/09/201929/01/2021An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
375Phase 2United 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
414EUCTR2018-003985-15-CZ
(EUCTR)
26/09/201931/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;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
415EUCTR2018-003278-28-CZ
(EUCTR)
25/09/201915/04/2019Safety, 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;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
416EUCTR2018-004694-27-DE
(EUCTR)
24/09/201924/05/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 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] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
417NCT03760003
(ClinicalTrials.gov)
September 23, 201929/11/2018Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative ColitisA Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid TreatmentUlcerative ColitisDrug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: PlaceboAbivax S.A.NULLCompleted18 Years75 YearsAll254Phase 2United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
418EUCTR2018-001605-93-BE
(EUCTR)
23/09/201907/06/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ABNULLNot RecruitingFemale: yes
Male: yes
375Phase 2United 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
419EUCTR2017-004496-31-NL
(EUCTR)
20/09/201927/09/2018A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of
420NCT03950232
(ClinicalTrials.gov)
September 20, 201913/5/2019An Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: EtrasimodArena PharmaceuticalsNULLRecruiting16 Years80 YearsAll912Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Thailand;Turkey;Ukraine;United Kingdom
421NCT03847467
(ClinicalTrials.gov)
September 20, 201912/2/2019Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF TherapyPilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF TherapyInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisDrug: 2'-Fucosyllactose;Other: PlaceboChildren's Hospital Medical Center, CincinnatiBroad Institute;University of Cincinnati;Connecticut Children's Medical CenterRecruiting11 Years25 YearsAll216Phase 1/Phase 2United States
422EUCTR2018-003985-15-NL
(EUCTR)
18/09/201909/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Portugal;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
423EUCTR2018-003987-29-BE
(EUCTR)
16/09/201901/07/2019An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative ColitisAn Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Portugal;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;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
424EUCTR2018-001605-93-FR
(EUCTR)
13/09/201925/06/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-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): noUnited 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
425EUCTR2018-002135-19-GR
(EUCTR)
13/09/201904/06/2019A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United 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
426EUCTR2018-002136-24-FR
(EUCTR)
10/09/201919/12/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3United 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
427NCT03885713
(ClinicalTrials.gov)
September 10, 20194/3/2019Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel DiseaseIdentification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry ApproachesInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisBiological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumabFundación de Investigación Biomédica - Hospital Universitario de La PrincesaNULLRecruiting18 YearsN/AAll180Phase 4Spain
428NCT04176588
(ClinicalTrials.gov)
September 10, 201922/11/2019A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative ColitisModerately to Severely Active Ulcerative ColitisDrug: Etrasimod;Drug: PlaceboEverstar Therapeutics LimitedNULLRecruiting18 Years75 YearsAll333Phase 3China
429EUCTR2017-004230-28-HU
(EUCTR)
06/09/201908/07/2019BI 655130 induction treatment in patients with moderate-to severe ulcerative colitisA Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece
430EUCTR2019-002070-31-DK
(EUCTR)
05/09/201924/06/2019Compliance 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 HvidovreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4Denmark
431EUCTR2017-004092-31-DE
(EUCTR)
05/09/201915/05/2019A study of the efficacy and safety of Mirikizumab in Ulcerative ColitisI6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 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: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
960Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
432NCT03937609
(ClinicalTrials.gov)
September 4, 201930/4/2019TITRATE (inducTIon for acuTe ulceRATivE Colitis)Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients With Acute Severe Ulcerative ColitisColitis, UlcerativeDrug: InfliximabAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)PfizerRecruiting18 YearsN/AAll120Phase 4Netherlands
433EUCTR2016-000642-62-HR
(EUCTR)
30/08/201920/01/2020A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, 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 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
434EUCTR2018-003558-26-BE
(EUCTR)
29/08/201927/05/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. 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
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
435EUCTR2018-003985-15-LT
(EUCTR)
27/08/201910/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;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
436NCT03724175
(ClinicalTrials.gov)
August 26, 201912/10/2018The Role of Secondary Bile Acids in Intestinal InflammationThe Role of Secondary Bile Acids in Intestinal InflammationUlcerative Colitis;PouchitisDrug: ursodiol (ursodeoxycholic acid, UDCA)Stanford UniversityNULLRecruiting18 Years70 YearsAll15Phase 2/Phase 3United States
437EUCTR2018-003985-15-EE
(EUCTR)
26/08/201915/07/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
372Phase 3United 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
438EUCTR2018-002135-19-DE
(EUCTR)
26/08/201925/02/2019A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United 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
439EUCTR2018-004694-27-IT
(EUCTR)
21/08/201925/01/2021Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis - na 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]
Product Name: BMS-986165
Product Code: [BMS-986165]
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Czechia;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
440EUCTR2018-004491-35-PL
(EUCTR)
19/08/201903/07/2019A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative ColitisA 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 CorporationNULLAuthorised-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): noUnited States;Czech Republic;Poland;Romania;Germany
441EUCTR2017-004092-31-HR
(EUCTR)
19/08/201920/01/2020A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis 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) - LUCENT 3 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: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noAustria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan;Turkey;Lithuania;Korea, Republic of;China;Moldova, Republic of;Latvia;Netherlands;Denmark;Australia;Malaysia;France;India;Switzerland;Italy;Israel;Russian Federation;Ireland;Ukraine;Spain;Slovakia;Taiwan;Saudi Arabia;United States;Serbia
442EUCTR2018-003985-15-HR
(EUCTR)
14/08/201924/12/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Lithuania;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
443NCT03861143
(ClinicalTrials.gov)
August 14, 201927/2/2019Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: PlaceboLandos Biopharma Inc.NULLCompleted18 Years65 YearsAll198Phase 2United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia
444EUCTR2017-004092-31-IT
(EUCTR)
14/08/201917/06/2021A study of the efficacy and safety of Mirikizumab in Ulcerative ColitisA 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) - LUCENT 3 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: Mirikizumab
Product Code: [LY3074828]
INN or Proposed INN: Mirikizumab
Other descriptive name: Mirikizumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
840Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
445EUCTR2018-004694-27-CZ
(EUCTR)
13/08/201919/07/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 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] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
446EUCTR2017-004092-31-ES
(EUCTR)
13/08/201911/06/2019A study of the efficacy and safety of Mirikizumab in Ulcerative ColitisI6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 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: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: mirikizumab
Other descriptive name: MIRIKIZUMAB
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
840Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan
447NCT03977480
(ClinicalTrials.gov)
August 13, 201927/4/2019Phase II Study of Hemay007 in Patients With Active Ulcerative ColitisA Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: Hemay007;Drug: PlaceboTianjin Hemay Pharmaceutical Co.,LtdNULLRecruiting18 Years70 YearsAll70Phase 2China
448NCT03869905
(ClinicalTrials.gov)
August 8, 20198/3/2019Aquamin® as an Adjuvant Intervention for Ulcerative ColitisAquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in RemissionUlcerative ColitisDrug: Aquamin®;Drug: Placebo first then Aquamin®James VaraniNULLRecruiting18 Years80 YearsAll40Phase 2United States
449EUCTR2018-001605-93-ES
(EUCTR)
07/08/201909/08/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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.NULLNot RecruitingFemale: yes
Male: yes
900Phase 2United 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
450EUCTR2018-003278-28-PL
(EUCTR)
03/08/201911/06/2019Safety, 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United 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
451ChiCTR1900024086
2019-08-012019-06-24Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled TrialsModified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials Ulcerative Colitisintervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNULLPending1875Bothintervention period:10;control period:10;N/AChina
452NCT04029649
(ClinicalTrials.gov)
August 201917/7/2019Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative ColitisThe Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled TrialUlcerative ColitisDrug: Beta-1,3/1,6-D-Glucan;Drug: PlaceboFakultas Kedokteran Universitas IndonesiaNULLNot yet recruiting18 YearsN/AAll204Phase 2/Phase 3Indonesia
453NCT03948919
(ClinicalTrials.gov)
July 31, 201910/5/2019Low Sulfur Fecal Transplant for Ulcerative ColitisLow Sulfur Fecal Transplant for Ulcerative ColitisUlcerative ColitisDrug: Fecal