In short
SAR444336 is being studied in clinical trials for adults with microscopic colitis who are in clinical remission. The trial is looking at whether SAR444336 can help maintain steroid-free remission and how safe and effective it is compared with placebo.
Key points
- SAR444336 is being studied in a Phase 2 clinical trial for adults with microscopic colitis who are already in clinical remission. The study compares SAR444336 with a matched placebo. Researchers want to see whether the treatment can help people stay in sustained steroid-free remission. The main outcome is the proportion of participants who remain in remission without steroids. The trial is authorised and plans to enroll 83 participants. This is an interventional study focused on both efficacy and safety.
Trial overview
The available trial is an interventional study, which means researchers assign a treatment so they can compare results fairly. It is studying SAR444336 in adults with microscopic colitis who are already in clinical remission. The study is designed to look at both efficacy and safety, with the brief summary stating that it will evaluate SAR444336 as steroid-free therapy compared with placebo.
Who can join the study
This trial is for adults with microscopic colitis who are in clinical remission. The source data do not give more detailed inclusion or exclusion rules, so the full eligibility criteria are not available here.
What is being measured
The main outcome is the proportion of participants with sustained steroid-free clinical remission. In simple terms, this means the study is checking how many people stay well over time without needing steroid medicine. This is the key way the trial will judge whether SAR444336 is helping people with microscopic colitis remain in remission.
Study design and treatment groups
The trial compares SAR444336 with a matched placebo. A placebo is a look-alike treatment that does not contain the active study medicine, and it helps researchers see whether the study drug makes a real difference. The intervention list also shows SAR444336 as a subcutaneous treatment, which means it is given under the skin.
Trial status and size
The study status is Authorised. It is a Phase 2 trial, which is a mid-stage study that looks more closely at whether a treatment works while continuing safety checks. The planned enrollment is 83 participants.