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

RecruitingPhase 2

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

Who can join

Ages 18 to 75 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Sanofi · Participants: 99 · Started: Jun 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06958536

Locations in the U.S.

ArizonaInvestigational Site Number: 8400024, Tucson
CaliforniaInvestigational Site Number: 8400005, Escondido
Investigational Site Number: 8400001, Lancaster
FloridaInvestigational Site Number: 8400017, Kissimmee
Investigational Site Number: 8400015, Lighthouse PT
Investigational Site Number 8400028, Miami
Investigational Site Number: 8400012, Miami
Investigational Site Number: 8400007, Orlando
Investigational Site Number: 8400011, Palmetto Bay
GeorgiaInvestigational Site Number: 8400019, Marietta
IowaInvestigational Site Number: 8400025, Iowa City
KansasInvestigational Site Number: 8400006, Kansas City
MassachusettsInvestigational Site Number: 8400022, Boston
MichiganInvestigational Site Number: 8400008, Wyoming
MissouriInvestigational Site Number: 8400013, St Louis
North CarolinaInvestigational Site Number: 8400003, Chapel Hill
PennsylvaniaInvestigational Site Number: 8400009, Harrisburg
TexasInvestigational Site Number: 8400002, Fredericksburg
UtahInvestigational Site Number: 8400016, Ogden
VirginiaInvestigational Site Number: 8400027, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.