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The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis — CONCLUDE  

Ulcerative Colitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04985968
Study type Interventional
Source InDex Pharmaceuticals
Contact
Status Terminated
Phase Phase 3
Start date November 24, 2021
Completion date December 20, 2023
View Details
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