Trial Details
Not RecruitingBasic Information
| Clinical ID | c5060 |
|---|---|
| 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 |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NULL |
|---|---|
| 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.;Therapeuti |
| Interventions | Product Name: CobitolimodPharmaceutical Form: Rectal solutionINN or Proposed INN: COBITOLIMODCAS Number: 1527479-55-5Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 250-Pharmaceutical form |
Participant Information
| Sponsor | InDex Pharmaceuticals AB |
|---|---|
| City | NULL |
| 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;B |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | NULL |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |