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The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis — CONDUCT  

Ulcerative Colitis Clinical Trial

Official title:
A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

Clinical Trial Summary

The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

Clinical Trial Description

This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6. Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03178669
Study type Interventional
Source InDex Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date June 21, 2017
Completion date August 30, 2019
View Details
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