NCT03178669

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: InDex Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	cobitolimod	Rectal administration
DRUG	Placebo	Solution manufactured to mimic cobitolimod

Timeline

• Start date: 2017-06-21
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2017-06-07
• Last updated: 2021-02-01
• Results posted: 2021-02-01

Locations

64 sites across 10 countries: Czechia, France, Germany, Hungary, Poland, Russia, Serbia, Spain, Sweden, Ukraine