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
Showing 1 to 10 of 33 diseases
| 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 | EUCTR2018-000334-35-NO (EUCTR) | 27/11/2019 | 12/06/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An 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 An open label, long term safety trial of BI 655130treatment in patients with moderate to severely ac ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY AN ... | Boehringer Ingelheim Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;No ... | ||
| 2 | EUCTR2018-000334-35-HU (EUCTR) | 31/10/2019 | 06/09/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An 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 An open label, long term safety trial of BI 655130treatment in patients with moderate to severely ac ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANT ... | Boehringer Ingelheim RCV GmbH&Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Norway;Netherlands;Germany;Japan;Korea, Republic of;Denmark;Australia;Belgium;Poland;Canada;Czech Republic;Hungary;Italy;United Kingdom;Russian Federation;Austria;Spain;Greece;United States Norway;Netherlands;Germany;Japan;Korea, Republic of;Denmark;Australia;Belgium;Poland;Canada;Czech Re ... | ||
| 3 | EUCTR2017-004230-28-CZ (EUCTR) | 04/10/2019 | 11/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A 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 A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safet ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 ANT ... | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Korea, 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 Korea, Republic of;China;Japan;Germany;Netherlands;Norway;Denmark;Australia;Belgium;Poland;Argentina ... | ||
| 4 | EUCTR2017-004230-28-HU (EUCTR) | 06/09/2019 | 08/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A 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 A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safet ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name ... | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Spain;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 Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Ar ... | ||
| 5 | EUCTR2017-004230-28-GR (EUCTR) | 01/07/2019 | 03/05/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A 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 A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safet ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 ANT ... | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Cze ... | ||
| 6 | EUCTR2017-004230-28-DK (EUCTR) | 14/06/2019 | 24/03/2019 | BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safet ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name ... | Boehringer Ingelheim Denmark A/S | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Cze ... | ||
| 7 | EUCTR2018-000334-35-NL (EUCTR) | 21/03/2019 | 29/08/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An 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 An open label, long term safety trial of BI 655130treatment in patients with moderate to severely ac ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANT ... | Boehringer Ingelheim bv Netherlands | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Ca ... | ||
| 8 | EUCTR2018-000334-35-PL (EUCTR) | 21/02/2019 | 07/12/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials An open label, long term safety trial of BI 655130(Spesolimab) treatment in patients with moderate t ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 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: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANT ... | Boehringer Ingelheim RCV GmbH&Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Po ... | ||
| 9 | EUCTR2018-000334-35-DE (EUCTR) | 12/12/2018 | 20/08/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials An open label, long term safety trial of BI 655130(Spesolimab) treatment in patients with moderate t ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | 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 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: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANT ... | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Po ... | ||
| 10 | EUCTR2018-000334-35-IT (EUCTR) | 30/10/2018 | 17/06/2021 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130(SPESOLIMAB) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials - - An open label, long term safety trial of BI 655130(SPESOLIMAB) treatment in patients with moderate t ... | 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] Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 1 ... | Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptiv ... | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Australia;Norway;Germany Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kin ... |