A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Study of an Investigational Study Drug for Moderate to Severe 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.
The purpose of this research study is to learn about the effects and safety of an investigational study drug compared with a placebo in people with moderate to severe Crohn’s disease. A placebo looks like the investigational study drug but does not contain active medication.
Participants will receive either the investigational study drug at one of different dose levels or a placebo. Some participants who are eligible may be able to continue into a longer period where everyone receives the investigational study drug.
Who can participate:
Adults with moderate to severe Crohn’s disease may be able to participate if they:
- Have had Crohn’s disease for at least three months
- Have moderate to severe Crohn’s disease
- Have tried at least one standard treatment or advanced therapy before, and it did not work well enough, stopped working, or caused difficult side effects
- Are on stable doses of certain Crohn’s disease medicines before screening
Study timeline and visits:
Participation lasts up to 168 weeks. For some eligible participants, this may include a longer period of up to 104 weeks where everyone receives the investigational study drug.
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