drugset / Trial / NCT04985968

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

NCT04985968 ↗

Phase 3 Terminated 171 enrolled InDex Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-11-24
Primary completion
2023-12-20
Completion
2023-12-20

Outcome

Outcome not reported

Stopped: “Due to futility”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobitolimod Oligonucleotide (other) 250 mg Rectal
Subject Cobitolimod Oligonucleotide (other) 500 mg Rectal

Indications