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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with microscopic colitis, a digestive system condition that causes inflammation of the large intestine. The study will test a new medication called SAR444336 in patients who have achieved remission (improvement of symptoms) while using budesonide, a steroid medication. The main purpose is to determine if SAR444336 can help maintain remission without the need for continued steroid treatment.

The study will compare SAR444336 to a placebo in patients whose microscopic colitis symptoms are currently under control with budesonide treatment. SAR444336 is given as a solution for injection that is administered under the skin (subcutaneous use). The treatment period will last for 20 weeks.

During the study, researchers will monitor how well participants maintain their improvement without using steroids. They will also track any side effects that may occur and measure how the body responds to the new medication. The study is designed so that neither the participants nor the doctors know who is receiving SAR444336 or placebo during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive SAR444336 or placebo (an inactive substance) through subcutaneous injection (under the skin).

    During this phase, your current budesonide treatment will be gradually discontinued.

    The treatment assignment is random and neither you nor the study staff will know which treatment you are receiving.

  2. Step 2

    Regular monitoring period

    Your condition will be monitored to assess if you maintain clinical remission (absence of symptoms) without steroid medication.

    Medical staff will track any side effects or reactions to the study medication.

    Blood samples will be collected to measure the levels of SAR444336 in your blood.

    The presence of antibodies (immune system proteins) against the study medication will be monitored.

  3. Step 3

    Safety assessments

    Regular checks will be performed to monitor for any side effects or adverse reactions.

    Your overall health status will be evaluated throughout the study.

    Any changes in your microscopic colitis symptoms will be documented.

  4. Step 4

    Study completion

    The study will continue until May 2027.

    A final evaluation will assess your response to the treatment.

    Your participation may end earlier if you experience significant side effects or if your condition worsens.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of microscopic colitis (a condition causing inflammation in the large intestine) verified through tissue examination
  • Must be currently taking budesonide (an anti-inflammatory steroid medication)
  • Must be in clinical remission (having no active symptoms) for at least 2 weeks before the screening visit
  • Must have experienced at least one relapse (return of symptoms) of microscopic colitis in the past 8 months that required treatment with budesonide
  • Must have a body mass index (BMI) between 18 and 35 kg/m² at the screening visit. BMI is a measure that uses your height and weight to determine if your weight is healthy
  • Must use appropriate contraceptive methods that comply with local regulations
  • Must be an adult (18 years or older)
  • Can be either male or female

Who cannot join the trial?

13 criteria

  • History of inflammatory bowel disease (chronic conditions affecting the digestive tract) other than microscopic colitis
  • Current or recent treatment with systemic corticosteroids (anti-inflammatory medications taken as pills or injections) within 4 weeks before starting the study
  • Active or recent gastrointestinal infection within 8 weeks before the study
  • History of major intestinal surgery or planned surgery during the study period
  • Current diagnosis of cancer or history of cancer within the past 5 years
  • Severe liver disease or abnormal liver function tests
  • Uncontrolled high blood pressure or significant heart disease
  • Active or chronic infection, including tuberculosis or hepatitis B or C
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within 30 days before this study
  • Known allergies to the study medication or its components
  • Conditions that could interfere with study participation or evaluation of results
  • Unable to provide informed consent or follow study procedures
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Investigated drugs

  • SAR444336

    An experimental medication being studied for treating microscopic colitis, a condition that causes inflammation in the intestines. This medication is being tested as a potential steroid-free treatment option for patients who have achieved remission with budesonide.

  • Budesonide

    A corticosteroid medication used to treat inflammation in the intestines. It helps control symptoms of microscopic colitis and bring the condition into remission. In this study, patients will have already achieved remission using this medication before starting the experimental treatment.

What is already known about the treatment

  • SAR444336

    An investigational medication currently being studied in clinical trials for the treatment of microscopic colitis, a digestive system disease. It is being evaluated as a potential steroid-free therapeutic option for patients who have achieved clinical remission with budesonide. The medication is being tested in a randomized, double-blind study against placebo to assess its efficacy, safety, and tolerability. While the exact mechanism of action is not publicly detailed in current medical literature, this experimental drug is being investigated for its potential role in maintaining remission in patients with inflammatory conditions of the digestive system.

  • Budesonide

    A corticosteroid medication administered orally or through inhalation, commonly used in the treatment of various inflammatory conditions including microscopic colitis. It works by reducing inflammation in the digestive tract by suppressing the immune system's inflammatory response at the local level. As a synthetic glucocorticoid, it belongs to the class of corticosteroid medications and has a more favorable side effect profile compared to traditional systemic steroids due to its targeted action and lower systemic absorption.

Investigated diseases

Microscopic Colitis – A chronic inflammatory condition affecting the large intestine (colon) that causes persistent watery diarrhea. The condition is characterized by inflammation that can only be seen when tissue from the colon is examined under a microscope. There are two main types: collagenous colitis and lymphocytic colitis, both causing similar symptoms. The inflammation leads to changes in how the colon absorbs and secretes water, resulting in chronic diarrhea. The condition typically develops gradually and can affect daily activities through frequent bowel movements.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519495-83-00Protocol codeACT18053Estimated enrolment83 patientsSponsorSanofi-Aventis Recherche & Developpement

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