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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease

Phase 2 Interventional Sanofi · NCT06958536

This trial will test whether two different doses of SAR442970 work better than placebo for people with moderate-to-severe Crohn's disease who have not had an adequate response or cannot tolerate standard or advanced therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment99 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsMethotrexate
Locations66 sites (Tucson, Arizona and 65 other locations)
Trial IDNCT06958536 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people diagnosed with moderate-to-severe Crohn's disease for at least three months who have had inadequate response, loss of response, or intolerance to at least one standard or advanced therapy and are on stable background medication prior to screening.

Not a fit: Patients with active ulcerative colitis or indeterminate colitis, certain unexcised colonic polyps or colonic mucosal dysplasia, those with conditions excluded by the protocol (such as short bowel syndrome), or those who do not meet the moderate-to-severe disease criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SAR442970 could provide a new treatment option that improves symptoms and disease control for people with moderate-to-severe Crohn's disease who have limited benefit from current therapies.

How similar studies have performed: Other biologic and small-molecule therapies targeting inflammatory pathways have produced benefits in Crohn's disease, but SAR442970's safety and efficacy remain to be shown in this phase 2b program.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Tucson, Arizona and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.