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Testing SAR442970 compared to placebo in adults with moderate to severe Crohn's disease

Fast replyInvestigationalNo placebo
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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 patients with moderate to severe Crohn's disease, which is a chronic inflammatory condition affecting the digestive tract. The research evaluates a new medication called SAR442970, which is given as an injection under the skin. The study aims to determine how well different doses of this medication work in improving the condition of the intestinal lining in people with Crohn's disease.

The study compares SAR442970 with placebo in patients who have not responded well enough to previous treatments. The medication or placebo will be administered through subcutaneous injections, which means the medicine is given under the skin. The maximum daily dose of the medication will be 150 milligrams, with a total maximum dose of 300 milligrams over the course of treatment.

The treatment period lasts for 52 weeks, during which patients will receive either the study medication or placebo. Throughout the study, doctors will monitor the condition of the intestinal lining and track various symptoms of Crohn's disease. They will also check how safe the medication is and how well patients tolerate it. Participants will have regular check-ups to assess their response to treatment and monitor for any side effects.

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

    You will undergo a screening process to confirm your eligibility for the study.

    A colonoscopy will be performed to assess your Crohn's disease activity.

    Your disease activity will be measured using a scoring system called CDAI (Crohn's Disease Activity Index).

  2. Step 2

    Treatment initiation

    You will be randomly assigned to receive either SAR442970 or placebo.

    The medication will be given as an injection under the skin (subcutaneous injection).

    This initial treatment period will last for 16 weeks.

  3. Step 3

    First assessment period

    At week 16, you will undergo another colonoscopy to evaluate your response to treatment.

    Your disease activity will be measured again using the CDAI score.

    Your quality of life will be assessed using specific questionnaires (IBDQ and FACIT-F).

  4. Step 4

    Extended treatment

    The treatment will continue until week 52.

    Regular assessments of your condition will be performed during this period.

    Blood samples will be taken to measure the medication levels in your body.

  5. Step 5

    Final evaluation

    At week 52, a final colonoscopy will be performed to assess your response to treatment.

    Your disease activity and clinical response will be evaluated one last time.

    The study will assess if you achieved both clinical improvement and healing of the intestinal lining.

Who can join the trial?

8 criteria

  • Age between 18 and 75 years old
  • Must have been diagnosed with Crohn's disease for at least 3 months before screening, confirmed by tissue sample (biopsy), endoscopy, or imaging tests
  • Must have moderate to severe active disease with: - A specific disease activity score (CDAI) between 220 and 450 - Evidence of disease activity on endoscopy - At least 4 very soft or liquid stools per day and/or daily abdominal pain
  • Must have previously received treatment with either: - Standard medications (such as 5-ASA, azathioprine, methotrexate, or corticosteroids) without adequate improvement, OR - Between 1 and 3 advanced therapies (such as biologics or small molecule drugs) without adequate improvement
  • If currently taking medications, doses must be stable for: - At least 2 weeks for 5-ASA compounds and corticosteroids - At least 4 weeks for azathioprine, 6-MP, methotrexate, or antibiotics
  • Must agree to use appropriate contraception: - Men must use condoms during the study and for 5 months after - Women must use highly effective contraception during the study and for 5 months after - Women must have a negative pregnancy test before starting
  • Must be willing to participate and follow study requirements
  • Must be able to provide written informed consent

Who cannot join the trial?

13 criteria

  • Current or history of intestinal strictures (narrowing of the intestine) or bowel surgery in the past 6 months
  • Active or history of severe infections, including tuberculosis, hepatitis B, or hepatitis C
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe allergic reactions or known hypersensitivity to study medications
  • Pregnant or breastfeeding women
  • Significant heart, liver, or kidney problems
  • Use of other biological treatments (specialized medications that affect the immune system) within the past 2-3 months
  • Active gastrointestinal infection or other serious infection requiring antibiotics
  • Major surgery planned during the study period
  • Participation in another clinical trial within the past 30 days
  • Current substance abuse or severe mental health conditions that could interfere with study participation
  • Live vaccines received within 4 weeks before starting the study
  • Conditions that could interfere with endoscopy procedure (examination of the intestine using a camera)
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Investigated drugs

SAR442970 is an investigational medication being studied for the treatment of Crohn's disease. It is designed to help reduce inflammation in the digestive tract of people with moderate to severe Crohn's disease. This medication is being tested to see if it can improve the appearance of the intestinal lining when viewed through an endoscope (a medical camera that examines the inside of the digestive tract).

What is already known about the treatment

SAR442970 - An investigational medication currently being studied in Phase 2 clinical trials for the treatment of moderate to severe Crohn's disease, a chronic inflammatory bowel condition. The drug is being evaluated for its efficacy in achieving endoscopic response, which refers to healing of the intestinal mucosa as observed through endoscopy. While the exact mechanism of action has not been publicly disclosed in the available data, it is being tested in a placebo-controlled setting to determine optimal dosing and safety profile in adult patients. The study is being conducted across multiple medical centers to evaluate different dose levels of the medication.

Investigated diseases

Crohn's Disease - A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly occurs in the small intestine and colon. The inflammation can penetrate deep into the layers of the bowel wall, causing pain, diarrhea, fatigue, and weight loss. The disease typically develops in patches, with healthy sections in between affected areas. Crohn's Disease can lead to complications such as narrowing of the intestines, formation of abnormal tunnels (fistulas), and nutritional deficiencies. The condition often follows a pattern of active periods (flares) alternating with periods of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517016-30-00Protocol codeDRI18450Estimated enrolment99 patientsSponsorSanofi-Aventis Recherche & Developpement

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).