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Study on the Effects of Eclitasertib in Adults with Moderate to Severe Ulcerative Colitis

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called SAR443122 in adults with moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine. The purpose of the study is to assess how effective and safe different doses of SAR443122 are for treating this condition.

Participants in the study will receive either the medication SAR443122 or a placebo, which looks like the medication but does not contain the active ingredient. The medication is taken orally in the form of a hard capsule. The study will last for up to 52 weeks, during which participants will be monitored to see how well the treatment works and to check for any side effects. The main goal is to see if participants achieve clinical remission, meaning their symptoms improve significantly, by the 12th week of the study.

Throughout the study, various assessments will be conducted to evaluate the participants' response to the treatment. These assessments include checking for improvements in symptoms, such as stool frequency and rectal bleeding, as well as examining the condition of the colon through endoscopy, a procedure that allows doctors to look inside the colon. The study will also track any adverse events, which are any unwanted effects that occur during the treatment period. The results will help determine the most effective dose of SAR443122 for managing ulcerative colitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication, SAR443122, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

  2. Step 2

    Medication administration

    You will take the medication in the form of a hard capsule by mouth. The specific dosage and frequency will be determined by the study team and may vary as the study aims to find the most effective dose.

  3. Step 3

    Treatment period

    The treatment period will last for 12 weeks. During this time, you will continue to take the assigned medication as instructed.

  4. Step 4

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effects of the medication. These assessments may include physical exams, blood tests, and questionnaires about your symptoms and quality of life.

  5. Step 5

    End of treatment evaluation

    At the end of the 12-week treatment period, your condition will be evaluated to determine if there has been any improvement in your symptoms. This will involve a review of your symptom scores and possibly an endoscopy, which is a procedure to look inside your colon.

  6. Step 6

    Follow-up

    After the treatment period, there may be additional follow-up visits to monitor your health and gather further information about the long-term effects of the medication.

Who can join the trial?

8 criteria

  • Participants must have clinical evidence of active Ulcerative Colitis (UC) for at least 3 months before the screening, confirmed by a procedure called endoscopy during the screening period.
  • Participants must have a minimum disease extent of 15 centimeters from the anal verge (the opening of the anus).
  • Participants must have not responded well, stopped responding, or cannot tolerate at least one of the following approved treatments: amino-salicylate, corticosteroids, immunosuppressants, biologics (except natalizumab, also known as Tysabri®), or small molecules.
  • Participants taking corticosteroids (a type of medication that reduces inflammation) must be on a stable dose for at least 2 weeks before and during the screening period.
  • Participants taking methotrexate, azathioprine, or 6-mercaptopurine (medications that suppress the immune system) must have been on treatment for at least 8 weeks before screening and on a stable dose for at least 4 weeks before and during the screening period.
  • Participants taking oral 5-aminosalicylates, mesalamine, or sulfasalazine (medications used to treat inflammation) must be on a stable dose for at least 4 weeks before and during the screening period.
  • Participants on advanced therapies must have either had their last dose at least 5 half-lives before randomization or have undetectable levels of the biologic in their blood before randomization. A half-life is the time it takes for the concentration of a drug in the body to reduce by half.
  • Participants must use contraception according to local regulations. Women should not be pregnant or breastfeeding.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who have had recent surgery or are planning to have surgery during the study period.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with certain infections that could affect the study results.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients with a history of certain types of cancer.
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Investigated drugs

SAR443122 is a medication being studied for its potential to help people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. This medication is being tested to see if it can reduce the symptoms of ulcerative colitis and improve the quality of life for patients. The study is looking at how effective and safe this medication is when used during the initial treatment period. By participating in this trial, researchers hope to find out if SAR443122 can be a beneficial treatment option for those suffering from this condition.

What is already known about the treatment

SAR443122 – SAR443122 is administered orally, meaning it is taken by mouth in the form of a pill or capsule. It is currently being studied in clinical trials to determine its effectiveness and safety for treating moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. The medication works by targeting specific molecules in the body that are involved in the inflammatory process, helping to reduce inflammation and alleviate symptoms. SAR443122 is classified as an anti-inflammatory agent, which means it is designed to reduce inflammation in the body.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can lead to frequent and urgent bowel movements. Over time, the disease can cause complications such as severe bleeding or perforation of the colon.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500290-14-01Protocol codeDRI16804Estimated enrolment325 patientsSponsorSanofi-Aventis Recherche & Developpement

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