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A Study of SAR442970 for Moderate-to-Severe Crohn's Disease

This study is looking into a new treatment called SAR442970 for people with moderate-to-severe Crohn's disease. You might be able to join if you are between 18 and 75 years old, have had Crohn's disease for at least 3 months, and your current or past treatments haven't worked well enough. Participants will receive either SAR442970 or a placebo (an inactive substance) through injections under the skin. The main goal is to see if SAR442970 helps improve the lining of the digestive tract (endoscopic response) after 16 weeks. The study is currently unclear about its recruitment status and plans to enroll about 99 people.

Study design
This is a Phase 2b, randomized, double-blind study with three groups, comparing different doses of SAR442970 to a placebo. About 99 participants are planned for enrollment.
What's involved
The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks. This includes a long-term extension period of up to 104 weeks for eligible participants.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for endoscopic response at Week 16. The total study duration is up to 168 weeks.

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NCT06958536

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Sanofi
~99 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:SAR442970Placebo

At a glance

Recruiting sites
66 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants who achieve endoscopic response at Week 16
Measured over From Baseline to Week 16

Conditions

Crohn's Disease

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Crohn Disease

Where it's being run

66 sites across 33 states
China8
Florida6
Poland6
Japan5
United Kingdom5
France3
Germany3
Spain3

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. Option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of participants who achieve endoscopic response at Week 16From Baseline to Week 16

    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.