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Clinical Trials in India / NCT06637631
Active, not recruiting Phase 2

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

NCT06637631 · tracked via the Priya Life Science India tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2024-12-10
Last updated
2026-09-11

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

SAR441566SAR441566 matching Placebo

SAR441566: Pharmaceutical form: Tablet Route of administration: Oral

SAR441566 matching Placebo: Pharmaceutical form: Tablet Route of administration: Oral

Study summary

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (139)

FacilityCityRegionStatus
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020 Sun City Arizona
Bristol Hospital- Site Number : 8400007 Bristol Connecticut
Novum Research- Site Number : 8400021 Clermont Florida
Homestead Associates in Research- Site Number : 8400012 Homestead Florida
Clinical Research of Osceola- Site Number : 8400013 Kissimmee Florida
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010 Miami Lakes Florida
GCP Clinical Research- Site Number : 8400004 Tampa Florida
GI Alliance - Glenview- Site Number : 8400015 Glenview Illinois
Illinois Gastroenterology Group- Site Number : 8400011 Gurnee Illinois
University of Michigan Health System - Ann Arbor- Site Number : 8400017 Ann Arbor Michigan
Gi Alliance - Flowood- Site Number : 8400019 Flowood Mississippi
Vector Clinical Trials- Site Number : 8400001 Las Vegas Nevada
Queens Village Primary Medical Center- Site Number : 8400005 Queens Village New York
Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014 Greenville North Carolina
Frontier Clinical Research - Uniontown- Site Number : 8400009 Uniontown Pennsylvania
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016 Charleston South Carolina
Gastro Health & Nutrition- Site Number : 8400003 Katy Texas
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002 Southlake Texas
Washington Gastroenterology - Tacoma- Site Number : 8400008 Tacoma Washington
Investigational Site Number : 0320002 San Miguel de Tucumán Tucumán Province
Investigational Site Number : 0320003 Buenos Aires Argentina
Investigational Site Number : 0320005 Buenos Aires Argentina
Investigational Site Number : 0320001 Buenos Aires Argentina
Investigational Site Number : 0320004 Buenos Aires Argentina
Investigational Site Number : 0320006 Buenos Aires Argentina
Investigational Site Number : 0360002 Sydney New South Wales
Investigational Site Number : 0360001 South Brisbane Queensland
Investigational Site Number : 0360003 Parkville Victoria
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001 Salvador Estado de Bahia
Hospital Moinhos de Vento- Site Number : 0760006 Porto Alegre Rio Grande do Sul
Hospital de Clinicas de Porto Alegre- Site Number : 0760007 Porto Alegre Rio Grande do Sul
Hospital Ernesto Dornelles- Site Number : 0760002 Porto Alegre Rio Grande do Sul
Pesquisare Saude- Site Number : 0760004 Santo André São Paulo
Investigational Site Number : 1000001 Gorna Oryahovitsa Bulgaria
Investigational Site Number : 1000004 Sofia Bulgaria
Investigational Site Number : 1000005 Sofia Bulgaria
Investigational Site Number : 1240001 Calgary Alberta
Investigational Site Number : 1240003 Montreal Quebec
Investigational Site Number : 1240005 Québec Quebec
Investigational Site Number : 1520006 Concepción Biobio

+ 99 more sites — see the full list on the official registry below.

More Sanofi trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06637631 on ClinicalTrials.gov ↗ ← All trials in India