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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
NCT06867094 · Sanofi
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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: 2028-05-11
Last updated: 2026-04-06
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
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (112)
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003Recruiting
Sun City, Arizona, United States
Bristol Hospital- Site Number : 8400017Recruiting
Bristol, Connecticut, United States
Novum Research- Site Number : 8400018Recruiting
Clermont, Florida, United States
Clinical Research of Osceola- Site Number : 8400012Recruiting
Kissimmee, Florida, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002Recruiting
Miami Lakes, Florida, United States
GCP Clinical Research- Site Number : 8400016Recruiting
Tampa, Florida, United States
GI Alliance - Glenview- Site Number : 8400005Recruiting
Glenview, Illinois, United States
Illinois Gastroenterology Group- Site Number : 8400004Recruiting
Gurnee, Illinois, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400010Recruiting
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400001Recruiting
New York, New York, United States
Queens Village Primary Medical Center- Site Number : 8400011Recruiting
Queens Village, New York, United States
NexGen Research- Site Number : 8400020Recruiting
Lima, Ohio, United States
Frontier Clinical Research - Uniontown- Site Number : 8400006Recruiting
Uniontown, Pennsylvania, United States
Gastro Health & Nutrition- Site Number : 8400007Recruiting
Katy, Texas, United States
SI Research Associates- Site Number : 8400019Recruiting
Lubbock, Texas, United States
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015Recruiting
Southlake, Texas, United States
University of Washington Medical Center- Site Number : 8400014Recruiting
Seattle, Washington, United States
Washington Gastroenterology - Tacoma- Site Number : 8400009Recruiting
Tacoma, Washington, United States
Investigational Site Number : 0320004Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320003Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320002Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320001Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320005Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0360003Recruiting
Kurralta Park, South Australia, Australia
Investigational Site Number : 0400003Recruiting
Graz, Austria
Investigational Site Number : 0400002Recruiting
Salzburg, Austria
Investigational Site Number : 0400001Recruiting
Vienna, Austria
Investigational Site Number : 0560002Recruiting
Ghent, Belgium
Investigational Site Number : 0560001Recruiting
Leuven, Belgium
Hospital de Clinicas de Porto Alegre- Site Number : 0760002Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles- Site Number : 0760003Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Investigational Site Number : 1000001Recruiting
Burgas, Bulgaria
Investigational Site Number : 1000003Recruiting
Rousse, Bulgaria
Investigational Site Number : 1000002Recruiting
Sofia, Bulgaria
Investigational Site Number : 1240004Recruiting
Kentville, Nova Scotia, Canada
Investigational Site Number : 1240005Recruiting
Richmond Hill, Ontario, Canada
Investigational Site Number : 1240001Recruiting
Québec, Quebec, Canada
Investigational Site Number : 1520002Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560002Recruiting
Guangzhou, China
Investigational Site Number : 1560001Recruiting
Hangzhou, China
Investigational Site Number : 1560003Recruiting
Huizhou, China
Investigational Site Number : 1560004Recruiting
Jiazhuang, China
Investigational Site Number : 1560014Recruiting
Linhai, China
Investigational Site Number : 1560008Recruiting
Luoyang, China
Investigational Site Number : 1560005Recruiting
Shanghai, China
Investigational Site Number : 1560007Recruiting
Shanghai, China
Investigational Site Number : 1560011Recruiting
Wuhan, China
Investigational Site Number : 2030001Recruiting
Olomouc, Czechia
Investigational Site Number : 2030002Recruiting
Ostrava, Czechia
Investigational Site Number : 2500003Recruiting
Nice, France
Investigational Site Number : 2500001Recruiting
Toulouse, France
Investigational Site Number : 2500002Recruiting
Vandœuvre-lès-Nancy, France
Investigational Site Number : 2680002Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680003Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680001Recruiting
Tbilisi, Georgia
Investigational Site Number : 2760005Recruiting
Berlin, Germany
Investigational Site Number : 2760008Recruiting
Berlin, Germany
Investigational Site Number : 2760010Recruiting
Duisburg, Germany
Investigational Site Number : 2760009Recruiting
Frankfurt, Germany
Investigational Site Number : 2760003Recruiting
Hanover, Germany
Investigational Site Number : 2760011Recruiting
Tübingen, Germany
Investigational Site Number : 2760006Recruiting
Ulm, Germany
Investigational Site Number : 3000001Recruiting
Athens, Greece
Investigational Site Number : 3000003Recruiting
Athens, Greece
Investigational Site Number : 3000002Recruiting
Heraklion, Greece
Investigational Site Number : 3480001Recruiting
Budapest, Hungary
Investigational Site Number : 3560005Recruiting
Hyderabad, India
Investigational Site Number : 3560003Recruiting
Jaipur, India
Investigational Site Number : 3560009Recruiting
Jaipur, India
Investigational Site Number : 3560002Recruiting
Kolkata, India
Investigational Site Number : 3560007Recruiting
Secunderabad, India
Investigational Site Number : 3560001Active Not Recruiting
Surat, India
Investigational Site Number : 3560010Recruiting
Visakhapatnam, India
Investigational Site Number : 3800006Recruiting
Genoa, Genova, Italy
Investigational Site Number : 3800002Recruiting
Milan, Milano, Italy
Investigational Site Number : 3800003Recruiting
Rozzano, Milano, Italy
Investigational Site Number : 3800008Recruiting
Naples, Napoli, Italy
Investigational Site Number : 3800001Recruiting
Padua, Padova, Italy
Investigational Site Number : 3800011Recruiting
Rome, Roma, Italy
Investigational Site Number : 3800010Recruiting
Turin, Torino, Italy
Investigational Site Number : 3800007Recruiting
Alessandria, Italy
Investigational Site Number : 3800009Recruiting
Palermo, Italy
Investigational Site Number : 3800004Recruiting
Pisa, Italy
Investigational Site Number : 3920005Recruiting
Kashiwa, Chiba, Japan
Investigational Site Number : 3920014Recruiting
Kure, Hiroshima, Japan
Investigational Site Number : 3920003Recruiting
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920007Recruiting
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920009Recruiting
Yahaba, Iwate, Japan
Investigational Site Number : 3920013Recruiting
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920002Recruiting
Bunkyo, Tokyo, Japan
Investigational Site Number : 3920011Recruiting
Kodaira, Tokyo, Japan
Investigational Site Number : 3920006Recruiting
Kofu, Yamanashi, Japan
Investigational Site Number : 3920012Recruiting
Hiroshima, Japan
Investigational Site Number : 3920016Recruiting
Kagoshima, Japan
Investigational Site Number : 3920001Recruiting
Niigata, Japan
Investigational Site Number : 3920010Recruiting
Osaka, Japan
Investigational Site Number : 3920015Recruiting
Tokyo, Japan
Investigational Site Number : 6160008Recruiting
Oświęcim, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160005Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160004Recruiting
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160001Recruiting
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002Recruiting
Rzeszów, Podkarpackie Voivodeship, Poland
Investigational Site Number : 7100002Recruiting
Cape Town, South Africa
Investigational Site Number : 7100001Recruiting
Cape Town, South Africa
Investigational Site Number : 7100004Recruiting
KwaDukuza, South Africa
Investigational Site Number : 7100003Recruiting
Pretoria, South Africa
Investigational Site Number : 7100005Recruiting
Pretoria, South Africa
Investigational Site Number : 7920002Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920003Recruiting
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920001Recruiting
Mersin, Turkey (Türkiye)