#1 Clinical Trials Search in Europe

SAR444336

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.

Table of Contents

Trial overview

The available trial is an interventional study, which means researchers assign a treatment so they can compare results fairly.[1] It is studying SAR444336 in adults with microscopic colitis who are already in clinical remission.[1] 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.[1]

Who can join the study

This trial is for adults with microscopic colitis who are in clinical remission.[1] The source data do not give more detailed inclusion or exclusion rules, so the full eligibility criteria are not available here.[1]

What is being measured

The main outcome is the proportion of participants with sustained steroid-free clinical remission.[1] In simple terms, this means the study is checking how many people stay well over time without needing steroid medicine.[1] This is the key way the trial will judge whether SAR444336 is helping people with microscopic colitis remain in remission.[1]

Study design and treatment groups

The trial compares SAR444336 with a matched placebo.[1] 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.[1] The intervention list also shows SAR444336 as a subcutaneous treatment, which means it is given under the skin.[1]

Trial status and size

The study status is Authorised.[1] 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.[1] The planned enrollment is 83 participants.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-519495-83-00Phase 2Microscopic colitisAuthorised83

FAQ

  • What is being studied in the SAR444336 trial? The trial is studying whether SAR444336 can help adults with microscopic colitis stay in clinical remission without steroids. It also compares SAR444336 with a matched placebo.
  • Who can take part in this trial? The study is for adults with microscopic colitis who are already in clinical remission. The trial data do not list more detailed eligibility rules.
  • What phase is the SAR444336 trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to check safety.
  • What condition is this trial focused on? The trial is focused on microscopic colitis, which is listed under digestive system diseases. The goal is to study treatment in people with this condition.
  • What is the main result the trial is measuring? The main result is the proportion of participants with sustained steroid-free clinical remission. This means the study checks how many people stay well over time without needing steroids.

Ongoing Clinical Trials on SAR444336

  • Study of SAR444336 in Adults with Microscopic Colitis Who Achieved Clinical Remission with Budesonide Treatment

    Recruiting

    2 1
    Investigated drugs:
    Belgium Denmark France Germany Hungary Italy +2

Glossary

  • Microscopic colitis: A condition that affects the colon, which is part of the large intestine. It is called microscopic because it is often seen under a microscope.
  • Clinical remission: A period when the signs and symptoms of a disease are reduced or gone.
  • Steroid-free: Not using steroid medicine. In this trial, the study is checking whether remission can be maintained without steroids.
  • Placebo: A treatment that looks like the study drug but does not contain the active study medicine. It helps researchers compare results fairly.
  • Matched placebo: A placebo made to look like the study treatment so the comparison is as fair as possible.
  • Phase 2: A mid-stage clinical trial that looks more closely at whether a treatment works and continues safety checks.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare the results.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: How well a treatment is tolerated and whether it causes problems.
  • Primary outcome: The main result the researchers plan to measure in a study.
  • Sustained remission: Staying in remission over time, not just for a short period.

References

  1. https://clinicaltrials.gov/study/2024-519495-83-00