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 UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.
This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).
* The study duration will be up to 59 weeks.
* The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
* The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
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:
* Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
* Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
* Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \>15 cm from the anal verge
* Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):
1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
* Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
* Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
* Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
* Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
* Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
* Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
* Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
* Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
* History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.
* If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
* Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
* Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
* Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
* Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
* Participants who received fecal microbial transplantation within 30 days prior to screening
* Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
* Participants who received IV corticosteroids within 14 days prior to screening or during screening period
* Screening laboratory and other analyses show abnormal results.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Primary outcome measure(s)
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS) — Week 12 Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability).
Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Trial sites (117)
Facility
City
Region
Status
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
Sun City
Arizona
Bristol Hospital- Site Number : 8400017
Bristol
Connecticut
Novum Research- Site Number : 8400018
Clermont
Florida
Clinical Research of Osceola- Site Number : 8400012
Kissimmee
Florida
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
Miami Lakes
Florida
GCP Clinical Research- Site Number : 8400016
Tampa
Florida
GI Alliance - Glenview- Site Number : 8400005
Glenview
Illinois
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee
Illinois
University of Michigan Health System - Ann Arbor- Site Number : 8400010
Ann Arbor
Michigan
Icahn School of Medicine at Mount Sinai- Site Number : 8400001
New York
New York
Queens Village Primary Medical Center- Site Number : 8400011
Queens Village
New York
NexGen Research- Site Number : 8400020
Lima
Ohio
Frontier Clinical Research - Uniontown- Site Number : 8400006
Uniontown
Pennsylvania
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
Charleston
South Carolina
Gastro Health & Nutrition- Site Number : 8400007
Katy
Texas
SI Research Associates- Site Number : 8400019
Lubbock
Texas
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
Southlake
Texas
University of Washington Medical Center- Site Number : 8400014
Seattle
Washington
Washington Gastroenterology - Tacoma- Site Number : 8400009
Tacoma
Washington
Investigational Site Number : 0320004
San Miguel de Tucumán
Tucumán Province
Investigational Site Number : 0320003
Buenos Aires
Argentina
Investigational Site Number : 0320002
Buenos Aires
Argentina
Investigational Site Number : 0320001
Buenos Aires
Argentina
Investigational Site Number : 0320005
Buenos Aires
Argentina
Investigational Site Number : 0360003
Kurralta Park
South Australia
Investigational Site Number : 0360005
Richmond
Victoria
Investigational Site Number : 0400002
Salzburg
Austria
Investigational Site Number : 0400001
Vienna
Austria
Investigational Site Number : 0560002
Ghent
Belgium
Investigational Site Number : 0560001
Leuven
Belgium
Hospital de Clinicas de Porto Alegre- Site Number : 0760002
Porto Alegre
Rio Grande do Sul
Hospital Ernesto Dornelles- Site Number : 0760003
Porto Alegre
Rio Grande do Sul
Investigational Site Number : 1000001
Burgas
Bulgaria
Investigational Site Number : 1000003
Rousse
Bulgaria
Investigational Site Number : 1000002
Sofia
Bulgaria
Investigational Site Number : 1240004
Kentville
Nova Scotia
Investigational Site Number : 1240006
Ajax
Ontario
Investigational Site Number : 1240005
Richmond Hill
Ontario
Investigational Site Number : 1240001
Québec
Quebec
Investigational Site Number : 1520002
Santiago
Reg Metropolitana de Santiago
+ 77 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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