RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. 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.

Official Title

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.

Quick Facts

Study Start:2024-12-10
Study Completion:2029-05-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06637631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female participants aged 18 to 75 years at the time of signing the ICF
  2. 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline
  3. 3. Confirmed diagnosis of moderate to severe CD as assessed by:
  4. * 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
  5. * stool frequency (SF), abdominal pain (AP) score
  6. 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
  7. 5. On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX ..)
  8. 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.
  1. 1. Participants with active UC, indeterminate colitis or short bowel syndrome
  2. 2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
  3. 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. 4. Participants with stool sample positive for infectious pathogens
  5. 5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
  6. 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. 7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
  8. 8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
  9. 9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
  10. 10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
  11. 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. 12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
  13. 13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
  14. 14. Participants who received fecal microbial transplantation within 30 days prior to screening
  15. 15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
  16. 16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
  17. 17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
  18. 18. Screening laboratory and other analyses show abnormal results

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
contact-us@sanofi.com

Study Locations (Sites)

GI Alliance - Sun City- Site Number : 8400020
Sun City, Arizona, 85351
United States
Connecticut Clinical Research Institute- Site Number : 8400007
Bristol, Connecticut, 06010
United States
Novum Research- Site Number : 8400021
Clermont, Florida, 34711
United States
Homestead Associates in Research- Site Number : 8400012
Homestead, Florida, 33033
United States
Clinical Research of Osceola- Site Number : 8400013
Kissimmee, Florida, 34741
United States
Wellness Clinical Research (WCR) - Site Number : 8400010
Miami Lakes, Florida, 33016
United States
GCP Clinical Research- Site Number : 8400004
Tampa, Florida, 33609
United States
GI Alliance - Glenview- Site Number : 8400015
Glenview, Illinois, 60026
United States
GI Alliance - Gurnee- Site Number : 8400011
Gurnee, Illinois, 60031
United States
University of Michigan- Site Number : 8400017
Ann Arbor, Michigan, 48109
United States
GIA Alliance - Flowood - Site Number : 8400019
Flowood, Mississippi, 39232
United States
Las Vegas Radiology - Las Vegas - West Sunset Road- Site Number : 8400001
Las Vegas, Nevada, 89113
United States
A1 Clinical Network- Site Number : 8400005
New York, New York, 11428
United States
Carolina Digestive Diseases- Site Number : 8400014
Greenville, North Carolina, 27834
United States
Frontier Clinical Research, LLC- Site Number : 8400009
Uniontown, Pennsylvania, 15401
United States
Vitality Digestive Institute Clinical Research- Site Number : 8400003
Katy, Texas, 77494
United States
GI Alliance - Southlake- Site Number : 8400002
Southlake, Texas, 76092
United States
Washington Gastroenterology- Site Number : 8400008
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10
Study Completion Date2029-05-23

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2029-05-23

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn's Disease