SAR442970 treatment for moderate-to-severe Crohn's disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, phase 2b, three-arm trial comparing two doses of the experimental drug SAR442970 to placebo in participants with moderate-to-severe Crohn's disease. Participants must have had a diagnosis for at least three months and prior exposure with inadequate response, loss of response, or intolerance to at least one standard or advanced therapy; background standard treatments may be continued if stable. The randomized treatment period lasts up to 158 weeks, followed by eligibility for an open-label long-term extension of up to 104 weeks, for a total study duration of up to 168 weeks. The trial is sponsored by Sanofi and conducted at specified investigational sites in the United States.

Why it matters

Who can join: the full rules

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 and having inadequate response to, loss of response to or intolerance to standard therapy with any of the following compounds: (5-Amino Salicylates (5-ASAs), 6-Mercaptopurine (6-MP), Azathioprine (AZA), Methotrexate (MTX), oral or corticosteroids 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, AZA, 6-MP, or 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.

Where it's running

• Investigational Site Number: 8400026
  Fairhope, Alabama, United States Recruiting
• Investigational Site Number: 8400024
  Tucson, Arizona, United States Recruiting
• Investigational Site Number: 8400005
  Escondido, California, United States Recruiting
• Investigational Site Number: 8400001
  Lancaster, California, United States Recruiting
• Investigational Site Number: 8400029
  San Diego, California, United States Recruiting
• Investigational Site Number: 8400032
  Colorado Springs, Colorado, United States Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.