96. Crohn disease Clinical trials / Disease details


Clinical trials : 2,400 Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000176-41-HU
(EUCTR)
07/05/202016/03/2020A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment 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: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy
2NCT03850509
(ClinicalTrials.gov)
February 25, 202015/2/2019Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active InflammationEfficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentCrohn's DiseaseDrug: OPS-2071 150 mg;Drug: OPS-2071 300 mg;Drug: OPS-2071 600 mg;Drug: Matching PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Iqvia Pty LtdTerminated18 Years70 YearsAll3Phase 2United States;Poland
3EUCTR2019-000176-41-IT
(EUCTR)
11/02/202005/11/2020A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment - - 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: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Otsuka Pharmaceutical Development and Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Belgium;Germany;Italy
4EUCTR2019-000176-41-PL
(EUCTR)
17/01/202006/09/2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment 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: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Belgium;Poland;Germany;Italy
5EUCTR2019-000176-41-DE
(EUCTR)
15/08/2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment 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: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy