96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-001866-14-IT (EUCTR) | 21/12/2021 | 12/10/2021 | Open-label Extension Study of Brazikumab in Crohn's Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) - INTREPID OLE | Moderately to Severely Active Crohn's Disease. MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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 MED2070 Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 2 | EUCTR2019-001866-14-HU (EUCTR) | 09/11/2021 | 02/08/2021 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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 MED2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 3 | EUCTR2019-001866-14-ES (EUCTR) | 27/10/2021 | 30/09/2020 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 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, AGN-151-598 | Allergan Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | China;Korea, Republic of;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany | ||
| 4 | EUCTR2018-004346-42-HU (EUCTR) | 15/10/2021 | 31/01/2020 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 5 | EUCTR2019-001866-14-PL (EUCTR) | 27/09/2021 | 08/09/2021 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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 MED2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 6 | EUCTR2019-001866-14-DE (EUCTR) | 10/09/2021 | 11/06/2021 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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 MED2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 7 | NCT04263831 (ClinicalTrials.gov) | March 11, 2021 | 7/2/2020 | LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE | LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE | Crohn Disease | Drug: Interleukin-2 (aldesleukin). | Boston Children's Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1/Phase 2 | United States |
| 8 | EUCTR2018-004346-42-IT (EUCTR) | 03/09/2020 | 24/05/2021 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease - 52-Week Phase 2b/3 Crohn's Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;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, AGN-151-598 Trade Name: Humira® Product Name: NA Product Code: [NA] INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anticorpo monoclonale umano anti-Interleuchina-23 Immunoglobulina G2 (IgG2); precedentemente denominato MEDI2070 e AMG 139 | ALLERGAN LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | ||
| 9 | EUCTR2018-004346-42-AT (EUCTR) | 18/06/2020 | 21/01/2020 | A study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severly Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Astrazeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 10 | EUCTR2018-004346-42-BG (EUCTR) | 28/05/2020 | 08/01/2020 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany | ||
| 11 | EUCTR2018-004346-42-RO (EUCTR) | 19/05/2020 | 18/03/2022 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;South Africa;Germany | ||
| 12 | EUCTR2018-004346-42-BE (EUCTR) | 15/04/2020 | 03/03/2020 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | ||
| 13 | EUCTR2018-004346-42-ES (EUCTR) | 26/12/2019 | 11/11/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 14 | EUCTR2018-004346-42-DE (EUCTR) | 10/12/2019 | 17/06/2019 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of;Canada;Hungary;Czech Republic;France;India;Italy;United Kingdom;Russian Federation;Israel;Austria;Ukraine;Spain;Slovakia;Taiwan;Czechia;United States | ||
| 15 | EUCTR2018-004346-42-FR (EUCTR) | 05/11/2019 | 10/07/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 16 | EUCTR2018-004346-42-GB (EUCTR) | 10/09/2019 | 30/05/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 17 | EUCTR2017-004997-32-DE (EUCTR) | 25/06/2019 | 14/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 18 | EUCTR2017-004997-32-HU (EUCTR) | 04/02/2019 | 04/04/2019 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 19 | EUCTR2017-004997-32-NL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 20 | EUCTR2017-004997-32-GB (EUCTR) | 04/01/2019 | 09/10/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States | ||
| 21 | EUCTR2017-004997-32-IE (EUCTR) | 14/12/2018 | 13/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: efmarodocokin alfa INN or Proposed INN: efmarodocokin alfa Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 22 | EUCTR2017-004997-32-ES (EUCTR) | 10/12/2018 | 17/09/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 23 | EUCTR2015-000609-38-GB (EUCTR) | 17/07/2017 | 10/05/2018 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 24 | EUCTR2015-000609-38-DE (EUCTR) | 10/05/2016 | 28/01/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 25 | EUCTR2015-000609-38-BE (EUCTR) | 21/04/2016 | 25/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 26 | EUCTR2015-000609-38-HU (EUCTR) | 04/04/2016 | 24/02/2016 | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 27 | EUCTR2015-000609-38-BG (EUCTR) | 30/03/2016 | 15/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 28 | EUCTR2015-000609-38-NL (EUCTR) | 24/03/2016 | 02/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - MEDI2070-LUX | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 29 | EUCTR2015-000609-38-IT (EUCTR) | 04/03/2016 | 21/02/2018 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to SevereCrohn's Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - nd | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 Other descriptive name: anticorpo monoclonale anti-IL-23 | MEDIMMUNE, LLC | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 30 | EUCTR2015-000609-38-ES (EUCTR) | 29/02/2016 | 08/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn?s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 31 | EUCTR2015-000609-38-CZ (EUCTR) | 15/02/2016 | 29/01/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 32 | EUCTR2013-002902-29-NL (EUCTR) | 12/02/2015 | 25/02/2014 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655066 10 mg/ml Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Name: BI 655066 90 mg/ml Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of | ||
| 33 | EUCTR2013-002902-29-DE (EUCTR) | 22/12/2014 | 08/08/2014 | Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: Risankizumab 10 mg/ml INN or Proposed INN: Risankizumab Product Code: Risankizumab 90 mg/ml INN or Proposed INN: Risankizumab | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 34 | EUCTR2013-002902-29-IE (EUCTR) | 03/02/2014 | 28/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 35 | NCT02031276 (ClinicalTrials.gov) | February 2014 | 16/12/2013 | Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease. | A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy | Crohn Disease | Drug: risankizumab IV;Drug: risankizumab SC;Drug: Placebo | AbbVie | Boehringer Ingelheim | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Belgium;Canada;France;Germany;Ireland;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom;United States |
| 36 | EUCTR2013-002902-29-BE (EUCTR) | 09/01/2014 | 20/09/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 37 | EUCTR2013-002902-29-ES (EUCTR) | 09/01/2014 | 05/12/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of | ||
| 38 | EUCTR2013-002902-29-GB (EUCTR) | 10/12/2013 | 26/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 39 | EUCTR2012-004098-26-DE (EUCTR) | 17/04/2013 | 03/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy | ||
| 40 | EUCTR2012-004098-26-FR (EUCTR) | 10/04/2013 | 25/09/2015 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy | ||
| 41 | NCT02676622 (ClinicalTrials.gov) | April 2013 | 21/4/2013 | Autologous Stem Cell Transplant for Refractory Crohn's Disease | A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's Disease | Crohn's Disease | Drug: mobilization of stem cells to prepare for Leukapheresis;Other: Leukapheresis- Collection of stem cells;Drug: Preparative regimen 4-6 weeks after Leukapheresis;Other: Stem Cell Transplant;Drug: Low-dose IL-2 administration | Nationwide Children's Hospital | NULL | Withdrawn | 12 Years | 29 Years | All | 0 | Phase 2 | NULL |
| 42 | EUCTR2012-004098-26-IT (EUCTR) | 25/02/2013 | 11/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active,moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 inSubjects with Moderate to Severe Crohn's Disease Who Have Failed or AreIntolerant to Anti-tumor Necrosis Factor-alpha Therapy - MEDI 2070 | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 Other descriptive name: anticorpo monoclonale anti IL-23 | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Spain;Germany;Italy;France;United States;Hungary;Czech Republic;Canada | ||
| 43 | EUCTR2012-004098-26-HU (EUCTR) | 11/02/2013 | 11/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Czech Republic;Hungary;Canada;Spain;Poland;Germany;Italy | ||
| 44 | EUCTR2012-004098-26-CZ (EUCTR) | 08/02/2013 | 07/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy | ||
| 45 | EUCTR2012-004098-26-ES (EUCTR) | 28/01/2013 | 22/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn´s disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn´s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn´s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 INN or Proposed INN: Not available Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Germany;Italy | ||
| 46 | NCT01266785 (ClinicalTrials.gov) | December 2010 | 23/12/2010 | Infliximab, Regulatory T Cells, IL2 and Crohn's Disease | Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease | Crohn's Disease | Drug: Infliximab | Oregon Health and Science University | Centocor, Inc. | Withdrawn | 18 Years | 70 Years | All | 0 | N/A | United States |
| 47 | EUCTR2019-001866-14-GB (EUCTR) | 09/04/2020 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 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, AGN-151-598 | AstraZeneca AB | NULL | NA | Female: yes Male: yes | 1000 | Phase 3 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | |||
| 48 | EUCTR2018-004346-42-PL (EUCTR) | 01/08/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);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, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | NA | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany |