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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

NCT06867094 · Sanofi
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Official title
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 Ulcerative Colitis
About this study
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 criteria
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.
Study design
Enrollment target: 204 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-28
Estimated completion: 2026-10-14
Last updated: 2026-09-11
Interventions
Drug: SAR441566Drug: SAR441566 matching Placebo
Primary outcomes
  • Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS) (Week 12)
Sponsor
Sanofi · industry
All locations (115)
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
Sun City, Arizona, United States
Bristol Hospital- Site Number : 8400017
Bristol, Connecticut, United States
Novum Research- Site Number : 8400018
Clermont, Florida, United States
Clinical Research of Osceola- Site Number : 8400012
Kissimmee, Florida, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
Miami Lakes, Florida, United States
GCP Clinical Research- Site Number : 8400016
Tampa, Florida, United States
GI Alliance - Glenview- Site Number : 8400005
Glenview, Illinois, United States
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee, Illinois, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400010
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400001
New York, New York, United States
Queens Village Primary Medical Center- Site Number : 8400011
Queens Village, New York, United States
NexGen Research- Site Number : 8400020
Lima, Ohio, United States
Frontier Clinical Research - Uniontown- Site Number : 8400006
Uniontown, Pennsylvania, United States
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
Charleston, South Carolina, United States
Gastro Health & Nutrition- Site Number : 8400007
Katy, Texas, United States
SI Research Associates- Site Number : 8400019
Lubbock, Texas, United States
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
Southlake, Texas, United States
University of Washington Medical Center- Site Number : 8400014
Seattle, Washington, United States
Washington Gastroenterology - Tacoma- Site Number : 8400009
Tacoma, Washington, United States
Investigational Site Number : 0320004
San Miguel de Tucumán, Tucumán Province, Argentina
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, Australia
Investigational Site Number : 0360005
Richmond, Victoria, Australia
Investigational Site Number : 0400003
Graz, Austria
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, Brazil
Hospital Ernesto Dornelles- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil
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, Canada
Investigational Site Number : 1240005
Richmond Hill, Ontario, Canada
Investigational Site Number : 1240001
Québec, Quebec, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560002
Guangzhou, China
Investigational Site Number : 1560001
Hangzhou, China
Investigational Site Number : 1560003
Huizhou, China
Investigational Site Number : 1560017
Huizhou, China
Investigational Site Number : 1560004
Jiazhuang, China
Investigational Site Number : 1560014
Linhai, China
Investigational Site Number : 1560008
Luoyang, China
Investigational Site Number : 1560005
Shanghai, China
Investigational Site Number : 1560011
Wuhan, China
Investigational Site Number : 2030001
Olomouc, Czechia
Investigational Site Number : 2030002
Ostrava, Czechia
Investigational Site Number : 2500003
Nice, France
Investigational Site Number : 2500001
Toulouse, France
Investigational Site Number : 2500002
Vandœuvre-lès-Nancy, France
Investigational Site Number : 2680002
Tbilisi, Georgia
Investigational Site Number : 2680003
Tbilisi, Georgia
Investigational Site Number : 2680001
Tbilisi, Georgia
Investigational Site Number : 2760005
Berlin, Germany
Investigational Site Number : 2760008
Berlin, Germany
Investigational Site Number : 2760010
Duisburg, Germany
Investigational Site Number : 2760009
Frankfurt, Germany
Investigational Site Number : 2760003
Hanover, Germany
Investigational Site Number : 2760011
Tübingen, Germany
Investigational Site Number : 2760006
Ulm, Germany
Investigational Site Number : 3000001
Athens, Greece
Investigational Site Number : 3000003
Athens, Greece
Investigational Site Number : 3000002
Heraklion, Greece
Investigational Site Number : 3480001
Budapest, Hungary
Investigational Site Number : 3560005
Hyderabad, India
Investigational Site Number : 3560003
Jaipur, India
Investigational Site Number : 3560009
Jaipur, India
Investigational Site Number : 3560002
Kolkata, India
Investigational Site Number : 3560004
Ludhiana, India
Investigational Site Number : 3560007
Secunderabad, India
Investigational Site Number : 3560001
Surat, India
Investigational Site Number : 3560010
Visakhapatnam, India
Investigational Site Number : 3800006
Genoa, Genova, Italy
Investigational Site Number : 3800002
Milan, Milano, Italy
Investigational Site Number : 3800003
Rozzano, Milano, Italy
Investigational Site Number : 3800008
Naples, Napoli, Italy
Investigational Site Number : 3800001
Padua, Padova, Italy
Investigational Site Number : 3800011
Rome, Roma, Italy
Investigational Site Number : 3800010
Turin, Torino, Italy
Investigational Site Number : 3800007
Alessandria, Italy
Investigational Site Number : 3800009
Palermo, Italy
Investigational Site Number : 3800004
Pisa, Italy
Investigational Site Number : 3920005
Kashiwa, Chiba, Japan
Investigational Site Number : 3920014
Kure, Hiroshima, Japan
Investigational Site Number : 3920003
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920007
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920009
Yahaba, Iwate, Japan
Investigational Site Number : 3920013
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920002
Bunkyo-Ku, Tokyo, Japan
Investigational Site Number : 3920011
Kodaira, Tokyo, Japan
Investigational Site Number : 3920006
Kofu, Yamanashi, Japan
Investigational Site Number : 3920012
Hiroshima, Japan
Investigational Site Number : 3920016
Kagoshima, Japan
Investigational Site Number : 3920001
Niigata, Japan
Investigational Site Number : 3920010
Osaka, Japan
Investigational Site Number : 3920015
Tokyo, Japan
Investigational Site Number : 6160008
Oświęcim, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160005
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002
Rzeszów, Podkarpackie Voivodeship, Poland
Investigational Site Number : 7100002
Cape Town, South Africa
Investigational Site Number : 7100001
Cape Town, South Africa
Investigational Site Number : 7100004
KwaDukuza, South Africa
Investigational Site Number : 7100003
Pretoria, South Africa
Investigational Site Number : 7100005
Pretoria, South Africa
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920003
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, Turkey (Türkiye)
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis · TrialPath