97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2031210352 | 28/02/2022 | 28/09/2021 | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis | Double-blinded Treatment Period : Oral administration of 2 capsules of 0.2 mg or 0.4 mg amiselimod or placebo once a day for 2 weeks, and oral administration of one cupsule once a day for 10 weeks. Open Label Extension Period: Oral administration of 0.4 mg amiselimod once a day for up to 36 weeks. | Kagiyama Shoji | NULL | Recruiting | >= 18age old | <= 75age old | Both | 35 | Phase 2 | USA;Australia;Taiwan;S. Korea;Belarus;Russia;Ukraine;Moldova;Georgia;Germany;Hungary;Czech Republic;Slovakia,;Serbia;Italy;Estonia;Bulgaria;Poland;Japan |
| 2 | NCT04857112 (ClinicalTrials.gov) | September 29, 2021 | 19/4/2021 | Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis | A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 336 | Phase 2 | United States |
| 3 | EUCTR2020-005232-30-SK (EUCTR) | 17/08/2021 | 09/06/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Serbia;United States;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Australia;Georgia;Bulgaria;Germany;Moldova, Republic of;Japan;Korea, Republic of | ||
| 4 | EUCTR2020-005232-30-DE (EUCTR) | 05/08/2021 | 29/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;France;Hungary;Poland;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;New Zealand;Korea, Republic of | ||
| 5 | EUCTR2020-005232-30-EE (EUCTR) | 27/07/2021 | 26/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Serbia;United States;Belarus;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of;Japan;Korea, Republic of | ||
| 6 | EUCTR2020-005232-30-BG (EUCTR) | 22/06/2021 | 02/06/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 7 | EUCTR2020-005232-30-HU (EUCTR) | 21/06/2021 | 23/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of |