Trial Details

Not Recruiting
Basic Information
Clinical ID c2374
Identifier EUCTR2021-002549-13-SK
Trial Title A Randomised Double-Blind Placebo-Controlled Phase III Clinical __Study to Evaluate the Efficacy and Safety of Cobitolimod as an __Induction and Maintenance Therapy in Participants with Moderate __to Severe Active Left-Sided Ulcerative Colitis__ - CONCLUDE
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1_Level: LLT_Classification code 10045365_Term: Ulcerative colitis_System Organ Class: 10017947 - Gastrointestinal disorders_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Product Name: Cobitolimod Pharmaceutical Form: Rectal solution INN or Proposed INN: COBITOLIMOD CAS Number: 1527479-55-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use Product Name: Cobitolimod Pharmaceutical Form: Rectal solution INN or Proposed INN: COBITOLIMOD CAS Number: 1527479-55-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use
Participant Information
Sponsor InDex Pharmaceuticals AB
City -
Country/Region Russia;United States;Czech Republic;North Korea;Portugal;Austria;Netherlands;Sweden;Brazil;Poland;Slovakia;Serbia;Bulgaria;France;Lithuania;Bosnia and Herzegovina;Croatia;Colombia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Spain;New Zealand;Canada;Belgium;Norway;China;Denmark;Mexico;South Africa;Italy;Georgia;Israel;Australia;ürkiye;Germany
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -