drugset / Trial / NCT04985968
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cobitolimod | Oligonucleotide (other) | 250 mg | Rectal |
| Subject | Cobitolimod | Oligonucleotide (other) | 500 mg | Rectal |