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Study of SAR441566 compared to placebo for adults with moderate to severe Crohn's disease

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What is this trial about?

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

This clinical trial focuses on evaluating a new medication called SAR441566 for people with Crohn's Disease, a chronic inflammatory condition that affects the digestive tract causing symptoms like abdominal pain and diarrhea. The study aims to determine how effective and safe different doses of this new oral medication are for treating moderate to severe forms of the disease.

The study will test SAR441566 against a placebo in the form of film-coated tablets. Participants will be randomly assigned to receive either the study medication or the placebo. The treatment period will last up to 104 weeks, during which doctors will monitor how well the medication works in reducing the signs and symptoms of Crohn's Disease.

Throughout the study, doctors will assess how well the treatment improves the appearance of the intestinal lining during examinations and whether it helps reduce disease symptoms. They will also monitor participants' overall well-being and check for any side effects that may occur during the treatment period. The medication will be taken by mouth according to a specific schedule determined by the study protocol.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be assessed based on specific criteria, including age (18-75 years), confirmed Crohn's disease diagnosis for at least 3 months

    The severity of your condition will be evaluated using the Crohn's Disease Activity Index (CDAI) and an endoscopy examination

    Your medical history, including previous treatments and their outcomes, will be reviewed

  2. Step 2

    Treatment phase begins

    You will be randomly assigned to receive either SAR441566 (study medication) or a placebo

    The medication will be provided as film-coated tablets for oral use

    You will continue taking your stable doses of standard treatments if applicable

  3. Step 3

    Monitoring period

    Your condition will be regularly assessed through endoscopic examinations

    Your symptoms will be monitored using the Crohn's Disease Activity Index

    Blood samples will be collected to measure medication levels in your body

    Your quality of life will be evaluated using a specialized questionnaire (Inflammatory Bowel Disease Questionnaire)

  4. Step 4

    Safety assessment

    Any side effects or changes in your health will be monitored and documented

    Special attention will be paid to potential immune system reactions

    Regular health checks will continue throughout the study period

  5. Step 5

    Study completion

    The study will evaluate if the medication improves your condition based on endoscopic examination results

    Your overall response to treatment will be assessed using multiple measures including disease activity and quality of life

    The study is expected to continue until May 2029

Who can join the trial?

11 criteria

  • Age between 18 and 75 years old at the time of signing the informed consent form
  • Have been diagnosed with Crohn's disease for at least 3 months before starting the study
  • Have moderate to severe Crohn's disease confirmed by:
    • A specific disease activity score (CDAI)
    • An endoscopy examination score (SES-CD)
    • Symptoms like stool frequency and abdominal pain
    • Previous treatment with standard therapies such as:
      • Basic medications (5-ASA, steroids, immune system medications, or antibiotics)
      • Advanced therapies (biological treatments or small molecule drugs)
      • Must have had inadequate response, lost response, or not tolerated at least one of these treatments
      • Must be on stable doses of current standard treatments before screening
      • Both men and women must use effective contraception methods according to local regulations
      • Women must not be pregnant or breastfeeding

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Pregnant or breastfeeding women
  • History of bowel surgery in the past 6 months
  • Active or recent serious infections (including tuberculosis)
  • Current cancer or history of cancer in the past 5 years
  • Severe heart conditions or uncontrolled high blood pressure
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • History of blood clotting disorders
  • Active or chronic hepatitis B or C infection
  • Current treatment with other investigational drugs
  • Known allergies to similar medications
  • Substance abuse or alcohol dependency within the past year
  • Severe mental health conditions that could interfere with the study
  • Unable to follow study procedures or attend regular visits
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Investigated drugs

SAR441566 is an experimental medication being studied for treating moderate to severe Crohn's Disease. It is being tested to see how effective different amounts of the medication are in improving the condition of the intestines as seen through endoscopy (a procedure that looks inside the digestive tract). This medication is still in early stages of research (Phase 2) and its exact way of working is being investigated to determine if it can help reduce inflammation and other symptoms in people with Crohn's Disease.

What is already known about the treatment

SAR441566 - An investigational medication currently undergoing Phase 2 clinical trials for the treatment of moderate to severe Crohn's disease, a chronic inflammatory bowel condition. This novel therapeutic agent is being studied in a randomized, double-blind, placebo-controlled trial to evaluate its efficacy and safety at different dose levels. While the specific mechanism of action and form of administration are not publicly disclosed in the current trial data, the medication is being investigated for its potential to improve endoscopic response in patients with Crohn's disease during the induction treatment phase. The drug represents a new approach in the therapeutic landscape of inflammatory bowel disease management, with ongoing research to determine its optimal dosing and clinical benefits.

Investigated diseases

Crohn's disease - A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus. The disease typically develops gradually and causes inflammation that spreads deep into the layers of affected bowel tissue. It most commonly affects the end of the small intestine and the beginning of the large intestine. Common manifestations include abdominal pain, diarrhea, fatigue, weight loss, and reduced appetite. The disease typically follows a pattern of active periods (flares) alternating with periods of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512633-32-00Protocol codeDRI18212Estimated enrolment568 patientsSponsorSanofi-Aventis Recherche & Developpement

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