The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)
ClinicalTrials.gov ID: NCT04985968
Sponsor: InDex Pharmaceuticals
Information provided by: InDex Pharmaceuticals (Responsible Party)
Last Update Posted: 2022-12-16
Brief Summary:
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.
Detailed Description:
This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.
In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.
OFFICIAL 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
INTERVENTION / TREATMENT
Drug: Cobitolimod 250 mg
Drug: Cobitolimod 500 mg
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-11-24 |
| Primary Completion (Estimated) | 2024-12-31 |
| Study Completion (Estimated) | 2024-12-31 |
| Enrollment (Estimated) | 440 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CSUC-01/21
|