NCT04985968

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: InDex Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Cobitolimod 250 mg	Rectal administration
DRUG	Cobitolimod 500 mg	Rectal administration
DRUG	Placebo	Rectal administration

Timeline

• Start date: 2021-11-24
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2021-08-02
• Last updated: 2023-12-27

Locations

203 sites across 28 countries: United States, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Croatia, Denmark, France, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study