A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease (CHROMA CD)
Effectiveness Study of an Investigational Medication for Crohn's Disease
Study Overview
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Crohn's Disease
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Age: 18 years - 75 years
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Gender: All
Inclusion Criteria:
- Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
- Confirmed diagnosis of moderate-to-severe CD
- History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
- On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion Criteria:
- Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome
- Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- Participants with following ongoing known complications of CD:
- Any manifestation that might require bowel surgery while enrolled in the study
- Participant with ostomy or ileoanal pouch
- Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
- Participant with surgical bowel resection within the past three months prior to screening, or a history of >3 bowel resections
- History of any other condition which, in the opinion of the Investigator, would put
the participant at risk by participation in the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
This study investigates the effectiveness of an investigational medication for treating moderate to severe Crohn's disease. Crohn's disease is a long-term condition that causes inflammation of the digestive tract, leading to symptoms such as abdominal pain and diarrhea. The study compares different doses of the investigational medication with a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Participants in the study will be randomly assigned to one of three study arms. They will receive either a dose of the investigational medication or a placebo. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo.
- Who can participate: Adults with moderate to severe Crohn's disease who have had the condition for at least 3 months may participate. Participants should have tried standard or advanced therapies without adequate results. They must be on stable doses of their current treatments before joining the study.
- Study details: Participants will be randomly assigned to one of three study arms, receiving either the investigational medication or a placebo.
- Study timelines: The study will last 168 weeks.
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