97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | 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 | EUCTR2016-003452-75-NL (EUCTR) | 23/06/2017 | 04/01/2017 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina | ||
| 2 | EUCTR2016-003452-75-HR (EUCTR) | 11/05/2017 | 07/06/2017 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina | ||
| 3 | EUCTR2016-003452-75-CZ (EUCTR) | 03/04/2017 | 19/12/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina;Slovenia;Serbia;United States | ||
| 4 | EUCTR2016-003452-75-LV (EUCTR) | 20/02/2017 | 23/11/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina | ||
| 5 | EUCTR2016-003452-75-HU (EUCTR) | 13/02/2017 | 01/12/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina | ||
| 6 | EUCTR2016-003452-75-BE (EUCTR) | 13/02/2017 | 07/12/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina | ||
| 7 | EUCTR2016-003452-75-PL (EUCTR) | 09/02/2017 | 04/01/2017 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina | ||
| 8 | NCT02895100 (ClinicalTrials.gov) | December 2016 | 4/9/2016 | Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis | A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis | Drug: PTG-100;Drug: Placebo | Protagonist Therapeutics, Inc. | NULL | Terminated | 18 Years | 80 Years | All | 100 | Phase 2 | United States;Australia;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Germany;Hungary;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Ukraine |