96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2019-001673-93-DK (EUCTR) | 07/04/2022 | 15/02/2022 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Austria;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 2 | JPRN-jRCT2031210677 | 18/03/2022 | 18/03/2022 | A study to test whether spesolimab helps people with Crohn's disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn's Disease | fibrostenotic Crohn's Disease | Investigational Drug: Spesolimab, Placebo Dose: 1200 mg spesolimab or placebo every 4 weeks (Day 1 to Week 8), then 1200 mg spesolimab or placebo every 8 weeks until Week 40 Mode of Administration: intervenous | Taguchi Aya | NULL | Pending | >= 18age old | <= 75age old | Both | 3 | Phase 2 | Australia;Austria;Belgium;Brazil;Canada;China;Denmark;France;Germany;Ireland;Israel;Italy;Republic of Korea;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom;United States;Japan |
| 3 | EUCTR2020-005770-99-NO (EUCTR) | 20/01/2022 | 23/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic 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 Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 4 | EUCTR2020-005770-99-PT (EUCTR) | 17/12/2021 | 27/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic 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 Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Portugal, Lda | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Romania;Norway;Germany;Japan;Sweden | ||
| 5 | EUCTR2020-005770-99-IT (EUCTR) | 24/11/2021 | 28/09/2021 | A study to test whether spesolimab helps people with Crohn's disease whohave symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trialto evaluate spesolimab (BI 655130) efficacy in patients with fibrostenoticCrohn's Disease - - | Fibrostenotic 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: BI 655130 Product Code: [BI 655130] INN or Proposed INN: SPESOLIMAB | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Aruba;Australia;Denmark;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 6 | EUCTR2020-005770-99-NL (EUCTR) | 12/11/2021 | 05/08/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic 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 Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 7 | EUCTR2020-005770-99-IE (EUCTR) | 09/11/2021 | 30/07/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic 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 Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 8 | NCT05013385 (ClinicalTrials.gov) | November 9, 2021 | 13/8/2021 | A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction | Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease | Fibrostenotic Crohn´s Disease | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Terminated | 18 Years | 75 Years | All | 5 | Phase 2 | United States;Canada;Japan;Sweden;Austria;Belgium;China;Denmark;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Norway;Portugal;Switzerland;Taiwan |
| 9 | EUCTR2020-005770-99-SE (EUCTR) | 20/10/2021 | 02/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic 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 Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 10 | EUCTR2020-005770-99-DK (EUCTR) | 22/09/2021 | 20/08/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic 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 Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 11 | EUCTR2019-001673-93-ES (EUCTR) | 23/04/2021 | 09/02/2021 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | 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 S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 12 | EUCTR2019-001673-93-BE (EUCTR) | 19/01/2021 | 23/11/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 13 | EUCTR2017-003090-34-DK (EUCTR) | 12/11/2020 | 15/06/2020 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Austria;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 14 | EUCTR2019-001673-93-HU (EUCTR) | 07/07/2020 | 09/06/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 15 | EUCTR2019-001673-93-DE (EUCTR) | 19/05/2020 | 02/03/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolilmab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 16 | EUCTR2019-001673-93-AT (EUCTR) | 05/02/2020 | 13/12/2019 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 17 | EUCTR2017-003090-34-HU (EUCTR) | 10/05/2019 | 25/03/2019 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Belgium;Austria;Netherlands;Germany | ||
| 18 | EUCTR2017-003090-34-NL (EUCTR) | 16/04/2019 | 19/12/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Netherlands BV | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of | ||
| 19 | EUCTR2017-003090-34-DE (EUCTR) | 18/02/2019 | 15/11/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 20 | EUCTR2017-003090-34-AT (EUCTR) | 05/02/2019 | 11/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 21 | EUCTR2017-003090-34-BE (EUCTR) | 28/11/2018 | 12/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of |