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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    440
  • sponsor
    InDex Pharmaceuticals
Updated on 7 October 2022
remission
left-sided ulcerative colitis

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.

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.

Details
Condition Ulcerative Colitis
Treatment Placebo, Cobitolimod 250 mg, Cobitolimod 500 mg
Clinical Study IdentifierNCT04985968
SponsorInDex Pharmaceuticals
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study

Exclusion Criteria

Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements
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