What is SAR441566 studying for Crohn's Disease?

SAR441566 is being studied to evaluate its safety and effectiveness in adults with moderate to severe Crohn's Disease. The trial compares different doses of SAR441566 to a placebo to see how well they help manage the condition. Sanofi is leading this research to better understand treatment options for patients.

Who may be eligible for this Crohn's Disease clinical trial?

Adults aged 18 to 75 with a confirmed diagnosis of moderate to severe Crohn's Disease for at least 3 months may be eligible. Both men and women can participate, but pregnant or breastfeeding women cannot join. Participants should have tried standard or advanced Crohn's treatments before. Please review eligibility criteria for more details.

Is there any cost to participate in this Crohn's Disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or other personal costs.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID06637631

A Phase 2, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of SAR441566 in Adults With Moderate to Severe Crohns Disease

Led by Sanofi · Updated on 2026-05-20

260

Participants Needed

138

Research Sites

96 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of SAR441566 in adults with moderate to severe Crohns Disease CD in this phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. The main goal is to compare different doses of SAR441566 with a placebo to see how well they work in treating this condition. The study lasts up to 59 weeks, including screening, treatment, and follow-up phases. Participants will be randomly assigned to receive one of three doses of SAR441566 or a matching placebo, all taken orally as tablets. The treatment phase includes a 12-week double-blind induction period followed by 40 weeks of maintenance. After this, eligible participants may join an open-label period lasting up to 40 weeks, but the total time in maintenance and open-label cannot exceed 40 weeks. During the study, participants will undergo assessments for endoscopic response, clinical remission, and patient-reported outcomes using various scores like the Crohns Disease Activity Index CDAI. Researchers will monitor drug levels, safety events, and quality of life measures over time. The total participation includes a 4-week screening, 52 weeks of treatment, and a 2-week follow-up for those not entering the long-term safety study.

CONDITIONS

Brief Title

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female participants aged 18 to 75 years at the time of signing the informed consent form
Confirmed diagnosis of Crohn's Disease for at least 3 months prior to baseline
Confirmed moderate to severe Crohn's Disease based on Crohn's Disease Activity Index (CDAI) score and Simple Endoscopic Score for Crohn's Disease (SES-CD)
History of prior exposure to standard or advanced Crohn's Disease treatments with inadequate response, loss of response, or intolerance
On stable doses of standard treatments before screening (such as oral 5-ASA compounds, corticosteroids, thiopurines, or methotrexate)
Use of contraception consistent with local regulations; women must not be pregnant or breastfeeding

You will not qualify if you...

Active ulcerative colitis, indeterminate colitis, or short bowel syndrome
Crohn's Disease limited to stomach, duodenum, jejunum, or perianal area without colonic or ileal involvement
Known complications such as fistula, abscess, symptomatic stricture, fulminant colitis, toxic megacolon, recent bowel resection within 3 months, or history of more than 3 bowel resections
Stool positive for infectious pathogens
Active tuberculosis or incompletely treated tuberculosis
Positive for hepatitis B surface antigen or core antibody, or hepatitis C antibody
Any other active, chronic, or recurrent infection including herpes zoster or herpes simplex
Known HIV infection or positive HIV-1 or HIV-2 serology
Active malignancies or lymphoproliferative disease within 5 years before screening
Colonic mucosal dysplasia or adenomatous polyps not removed during colonoscopy
Recent infections requiring IV or oral anti-infective treatment
Need for or receiving parental nutrition or exclusive enteral nutrition
Recent use of cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, or fecal microbial transplantation
Recent use of IV corticosteroids or therapeutic enema/suppository (other than for colonoscopy)
Abnormal screening laboratory or other analysis results

Research Team

Trial Transparency email recommended (Toll free for US & Canada)

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