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Study of SAR442970 to treat moderate to severe ulcerative colitis in adults

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 ulcerative colitis, a chronic inflammatory condition affecting the large intestine. The research evaluates a new medication called SAR442970, which is given as a solution for injection under the skin (subcutaneous injection). The purpose is to determine if different doses of this medication can help patients achieve remission of their disease.

During the study, participants will receive either SAR442970 or placebo for 16 weeks, followed by a longer treatment period of up to 52 weeks. The medication is administered through injections under the skin, with doses up to 300 milligrams. Patients' response to treatment will be monitored through various examinations of the intestine and assessment of disease symptoms.

The study will look at how well the treatment works by measuring improvements in intestinal inflammation, bowel movements, and overall disease activity. The research will also track any side effects that may occur during the treatment period. Throughout the study, researchers will monitor the levels of the medication in patients' blood and check for the development of antibodies against the treatment.

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 phase

    You will participate in a clinical trial testing SAR442970, a new medication for moderate to severe ulcerative colitis.

    The trial consists of two main periods: a 16-week initial treatment phase and a longer follow-up period lasting up to 52 weeks.

  2. Step 2

    Medication administration

    You will receive either SAR442970 or a placebo through subcutaneous injection (injection under the skin).

    The medication will be given in different doses to evaluate which amount works best.

    If you are currently taking other medications for ulcerative colitis, some may need to remain at stable doses during the trial.

  3. Step 3

    16-week evaluation

    After 16 weeks of treatment, your condition will be evaluated to check if the medication is working.

    The evaluation includes an examination of your colon using an endoscope (a small camera) to assess healing.

    Your symptoms will be monitored using a scoring system that measures factors such as stool frequency and rectal bleeding.

  4. Step 4

    52-week follow-up

    The trial continues for up to 52 weeks to evaluate long-term effects.

    Regular assessments will check your response to treatment.

    Blood samples will be taken to measure medication levels and monitor your health.

    The study will evaluate if you achieve remission (improvement of symptoms) and if you can reduce or stop taking corticosteroids if applicable.

  5. Step 5

    Final evaluation

    At the end of the trial, a final evaluation will assess the overall effectiveness of the treatment.

    The assessment includes endoscopy, blood tests, and symptom evaluation.

    Your quality of life related to inflammatory bowel disease will be evaluated using a questionnaire.

Who can join the trial?

12 criteria

  • Must be between 18 and 75 years old when signing the consent form
  • If diagnosed with Ulcerative Colitis for 8 or more years, must have completed colorectal cancer screening according to local guidelines
  • Must use appropriate contraception methods: - Men must avoid donating sperm and use condoms - Women must either be unable to become pregnant or use highly effective contraception - Women who can become pregnant must have a negative pregnancy test
  • Must be able to give informed consent and follow study requirements
  • Must have active Ulcerative Colitis for more than 3 months before screening, confirmed by examination of the bowel (endoscopy)
  • Must have moderate to severe Ulcerative Colitis with specific disease activity scores
  • Must have disease affecting at least 15 centimeters of the bowel from the anal area
  • Must have previous treatment experience with either: - Standard treatments (such as aminosalicylates, corticosteroids, or immunosuppressants) with inadequate results, OR - Advanced treatments (such as biological therapies) with inadequate results
  • If taking oral corticosteroids, must be on a stable dose for at least 2 weeks before screening
  • If taking certain medications (methotrexate, azathioprine, or 6-mercaptopurine), must be on them for at least 8 weeks with a stable dose for 4 weeks before screening
  • If taking aminosalicylates, must be on a stable dose for at least 4 weeks before screening
  • If previously taking advanced treatments, must have stopped them at least 8 weeks before joining the study or have undetectable levels in blood

Who cannot join the trial?

14 criteria

  • History of inflammatory bowel conditions other than Ulcerative Colitis (conditions causing inflammation in digestive tract)
  • Current or past cancer diagnosis within the last 5 years (except successfully treated non-melanoma skin cancer)
  • Active or chronic infections, including tuberculosis, HIV, hepatitis B, or hepatitis C
  • Severe liver problems or abnormal liver function tests
  • Significant heart conditions or uncontrolled high blood pressure
  • History of blood clots or bleeding disorders
  • Recent major surgery within the past 8 weeks
  • Current pregnancy or breastfeeding
  • Use of other investigational drugs within 30 days or 5 half-lives before the study
  • History of alcohol or drug abuse within the past 6 months
  • Mental health conditions that could interfere with study participation
  • Any vaccination with live or attenuated vaccines within 4 weeks before the study
  • Previous treatment with SAR442970 or similar medications
  • Severe allergic reactions to any medications in the past
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Investigated drugs

SAR442970 is an investigational medication being studied for treating moderate to severe ulcerative colitis (UC). It is a new drug that is being tested to see if it can help patients achieve remission, which means reducing or eliminating the symptoms of UC. UC is a condition that causes inflammation and sores in the lining of the large intestine, leading to symptoms like diarrhea, abdominal pain, and bleeding. The medication is being tested in different dose levels to find the most effective and safe amount for patients.

What is already known about the treatment

SAR442970 - An investigational medication currently being studied in Phase 2b clinical trials for the treatment of moderate to severe Ulcerative Colitis (UC). This experimental drug is being evaluated for its efficacy in inducing clinical remission in patients with UC, though its specific method of administration has not been disclosed in the provided data. SAR442970 represents a new potential therapeutic option in the field of gastroenterology and inflammatory bowel disease treatment, with ongoing research to determine its optimal dosing regimen and safety profile. While the exact molecular mechanism of action is not specified in the source data, the medication is being tested in a rigorous, double-blind, placebo-controlled study design to establish its therapeutic value in managing ulcerative colitis symptoms.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract's innermost lining, leading to recurring episodes of abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and lower colon but may spread continuously to involve the entire colon. Symptoms tend to develop gradually and can range from mild to severe, with periods of active disease alternating with periods of remission. The inflammation causes the colon to empty frequently, resulting in diarrhea and urgency to have bowel movements.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515241-41-00Protocol codeACT18134Estimated enrolment165 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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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).