A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
NCT ID: NCT06867094
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
204 participants
INTERVENTIONAL
2025-03-28
2028-05-11
Brief Summary
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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.
* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR441566 dose regimen 1
Participants will receive SAR441566 dose regimen 1
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 dose regimen 2
Participants will receive SAR441566 dose regimen 2
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 dose regimen 3
Participants will receive SAR441566 dose regimen 3
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Participants will receive SAR441566-matching placebo
SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Interventions
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SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
Eligibility Criteria
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Inclusion Criteria
* 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 combination of both):
1. No prior exposure to Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: 5-ASA, 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. Inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (such as TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or experimental biologic UC therapeutics), 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 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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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
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- 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 : 0360001
Mackay, Queensland, Australia
Investigational Site Number : 0360003
Kurralta Park, South Australia, Australia
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
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 : 1560004
Jiazhuang, , China
Investigational Site Number : 1560014
Linhai, , China
Investigational Site Number : 1560008
Luoyang, , China
Investigational Site Number : 1560005
Shanghai, , China
Investigational Site Number : 1560007
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 : 2760006
Ulm, , Germany
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000003
Athens, , Greece
Investigational Site Number : 3000002
Heraklion, , Greece
Investigational Site Number : 3560005
Hyderabad, , India
Investigational Site Number : 3560003
Jaipur, , India
Investigational Site Number : 3560009
Jaipur, , 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 : 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
Morioka, Iwate, Japan
Investigational Site Number : 3920013
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920002
Bunkyo, 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 : 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 : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, , Turkey (Türkiye)
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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DRI17822 Plain Language Results Summary
Other Identifiers
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U1111-1308-9729
Identifier Type: OTHER
Identifier Source: secondary_id
2025-520705-12
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRI17822
Identifier Type: -
Identifier Source: org_study_id