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Evaluating SAR441566 for treating Crohn's Disease

A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.

Phase 2 Interventional Sanofi · NCT06637631

This study is testing a new medication called SAR441566 to see if it can help adults with moderate to severe Crohn's Disease feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment260 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsnatalizumab
Locations138 sites (Sun City, Arizona and 137 other locations)
Trial IDNCT06637631 on ClinicalTrials.gov

What this trial studies

This phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease. Participants will undergo a screening period followed by a 52-week treatment phase that includes a 12-week induction and a 40-week maintenance period. Eligible participants may also enter an extension phase for additional treatment. The study will compare different doses of SAR441566 against a placebo to determine its effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of moderate to severe Crohn's Disease who have not responded adequately to previous treatments.

Not a fit: Patients with mild Crohn's Disease or those who have not previously tried standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from moderate to severe Crohn's Disease.

How similar studies have performed: Other studies have shown promise with similar biologic therapies for Crohn's Disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Male or female participants aged 18 to 75 years at the time of signing the ICF
2. Confirmed diagnosis of CD for at least 3 months prior to Baseline
3. Confirmed diagnosis of moderate to severe CD as assessed by:

   * Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
   * stool frequency (SF), abdominal pain (AP) score
4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
5. On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)
6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Participants with active UC, indeterminate colitis or short bowel syndrome
2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3 bowel resections
4. Participants with stool sample positive for infectious pathogens
5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
14. Participants who received fecal microbial transplantation within 30 days prior to screening
15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
18. Screening laboratory and other analyses show abnormal results

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

Sun City, Arizona and 137 other locations

+88 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 2026-06-15 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.