A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Investigation of Efficacy and Safety of an Investigational Medication in 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 efficacy and safety of an investigational medication in patients with moderate to severe Crohn's disease. The study involves different doses of the investigational medication compared to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Participants will be randomly assigned to one of three study arms. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the investigational medication or the placebo. The study includes a long-term extension period for eligible participants.
- Who can participate: Adults diagnosed with moderate to severe Crohn's Disease for at least 3 months may be eligible. Participants should have tried standard treatments or advanced therapies without adequate response. Stable use of standard treatments is required before screening.
- Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The study is double-blind, meaning neither participants nor researchers know who receives the investigational medication. An open-label extension period is available for eligible participants.
- Study timelines: The study will last up to 168 weeks.
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