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)
Proportion of participants achieving endoscopic response — Week 12 Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD).
The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Trial sites (139)
Facility
City
Region
Status
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.
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.
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