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

NCT06867094 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI17822U1111-1308-97292025-520705-12
• Study Type: interventional
• Target: 204
• Locations: 21 countries
• Sites: 112

Brief 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.

Conditions

Colitis Ulcerative

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)

  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.

  Week 12

Secondary Outcomes (15)

• Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)

  Week 12

• Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)

  Week 12

• Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)

  Week 12

• Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12

  Week 12

• Proportion of participants achieving endoscopic remission at Week 12

  Week 12

Study Arms (4)

SAR441566 dose regimen 1

EXPERIMENTAL

Participants will receive SAR441566 dose regimen 1

Drug: SAR441566

SAR441566 dose regimen 2

EXPERIMENTAL

Participants will receive SAR441566 dose regimen 2

Drug: SAR441566

SAR441566 dose regimen 3

EXPERIMENTAL

Participants will receive SAR441566 dose regimen 3

Drug: SAR441566

Placebo

PLACEBO COMPARATOR

Participants will receive SAR441566-matching placebo

Drug: SAR441566 matching Placebo

Interventions

SAR441566 DRUG

Pharmaceutical form: Tablet Route of administration: Oral

SAR441566 dose regimen 1; SAR441566 dose regimen 2; SAR441566 dose regimen 3

SAR441566 matching Placebo DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"):
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (115)

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003

Sun City, Arizona, 85351, United States

RECRUITING

Bristol Hospital- Site Number : 8400017

Bristol, Connecticut, 06010, United States

RECRUITING

Novum Research- Site Number : 8400018

Clermont, Florida, 34711, United States

RECRUITING

Clinical Research of Osceola- Site Number : 8400012

Kissimmee, Florida, 34741, United States

RECRUITING

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002

Miami Lakes, Florida, 33016, United States

RECRUITING

GCP Clinical Research- Site Number : 8400016

Tampa, Florida, 33609, United States

RECRUITING

GI Alliance - Glenview- Site Number : 8400005

Glenview, Illinois, 60026, United States

RECRUITING

Illinois Gastroenterology Group- Site Number : 8400004

Gurnee, Illinois, 60031, United States

RECRUITING

University of Michigan Health System - Ann Arbor- Site Number : 8400010

Ann Arbor, Michigan, 48109, United States

RECRUITING

Icahn School of Medicine at Mount Sinai- Site Number : 8400001

New York, New York, 10029, United States

RECRUITING

Queens Village Primary Medical Center- Site Number : 8400011

Queens Village, New York, 11428, United States

RECRUITING

NexGen Research- Site Number : 8400020

Lima, Ohio, 45805, United States

RECRUITING

Frontier Clinical Research - Uniontown- Site Number : 8400006

Uniontown, Pennsylvania, 15401, United States

RECRUITING

Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008

Charleston, South Carolina, 29401, United States

RECRUITING

Gastro Health & Nutrition- Site Number : 8400007

Katy, Texas, 77494, United States

RECRUITING

SI Research Associates- Site Number : 8400019

Lubbock, Texas, 79424, United States

RECRUITING

Texas Digestive Disease Consultants - Southlake- Site Number : 8400015

Southlake, Texas, 76092, United States

RECRUITING

University of Washington Medical Center- Site Number : 8400014

Seattle, Washington, 98195, United States

RECRUITING

Washington Gastroenterology - Tacoma- Site Number : 8400009

Tacoma, Washington, 98405, United States

RECRUITING

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Investigational Site Number : 0320003

Buenos Aires, 1006, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1023, Argentina

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1061, Argentina

RECRUITING

Investigational Site Number : 0320005

Buenos Aires, 1125, Argentina

RECRUITING

Investigational Site Number : 0360003

Kurralta Park, South Australia, 5037, Australia

RECRUITING

Investigational Site Number : 0400003

Graz, 8036, Austria

RECRUITING

Investigational Site Number : 0400002

Salzburg, 5020, Austria

RECRUITING

Investigational Site Number : 0400001

Vienna, 1090, Austria

RECRUITING

Investigational Site Number : 0560002

Ghent, 9000, Belgium

RECRUITING

Investigational Site Number : 0560001

Leuven, 3000, Belgium

RECRUITING

Hospital de Clinicas de Porto Alegre- Site Number : 0760002

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

Hospital Ernesto Dornelles- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

RECRUITING

Investigational Site Number : 1000001

Burgas, 8000, Bulgaria

RECRUITING

Investigational Site Number : 1000003

Rousse, 7002, Bulgaria

RECRUITING

Investigational Site Number : 1000002

Sofia, 1612, Bulgaria

RECRUITING

Investigational Site Number : 1240004

Kentville, Nova Scotia, B4N 0A3, Canada

RECRUITING

Investigational Site Number : 1240005

Richmond Hill, Ontario, L4C 9M7, Canada

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Investigational Site Number : 1240001

Québec, Quebec, G1N 4V3, Canada

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Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7500010, Chile

RECRUITING

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8331143, Chile

RECRUITING

Investigational Site Number : 1560002

Guangzhou, 510655, China

RECRUITING

Investigational Site Number : 1560001

Hangzhou, 310016, China

RECRUITING

Investigational Site Number : 1560003

Huizhou, 516001, China

RECRUITING

Investigational Site Number : 1560017

Huizhou, 516001, China

RECRUITING

Investigational Site Number : 1560004

Jiazhuang, 050000, China

RECRUITING

Investigational Site Number : 1560014

Linhai, 317000, China

RECRUITING

Investigational Site Number : 1560008

Luoyang, 471003, China

RECRUITING

Investigational Site Number : 1560005

Shanghai, 200120, China

RECRUITING

Investigational Site Number : 1560007

Shanghai, 200127, China

RECRUITING

Investigational Site Number : 1560011

Wuhan, 430014, China

RECRUITING

Investigational Site Number : 2030001

Olomouc, 779 00, Czechia

RECRUITING

Investigational Site Number : 2030002

Ostrava, 710 00, Czechia

RECRUITING

Investigational Site Number : 2500003

Nice, 06202, France

RECRUITING

Investigational Site Number : 2500001

Toulouse, 31059, France

RECRUITING

Investigational Site Number : 2500002

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Investigational Site Number : 2680002

Tbilisi, 0144, Georgia

RECRUITING

Investigational Site Number : 2680003

Tbilisi, 0160, Georgia

RECRUITING

Investigational Site Number : 2680001

Tbilisi, 0180, Georgia

RECRUITING

Investigational Site Number : 2760005

Berlin, 10117, Germany

RECRUITING

Investigational Site Number : 2760008

Berlin, 14050, Germany

RECRUITING

Investigational Site Number : 2760010

Duisburg, 47055, Germany

RECRUITING

Investigational Site Number : 2760009

Frankfurt, 60590, Germany

RECRUITING

Investigational Site Number : 2760003

Hanover, 30625, Germany

RECRUITING

Investigational Site Number : 2760011

Tübingen, 72076, Germany

RECRUITING

Investigational Site Number : 2760006

Ulm, 89081, Germany

RECRUITING

Investigational Site Number : 3000001

Athens, 106 76, Greece

RECRUITING

Investigational Site Number : 3000003

Athens, 124 62, Greece

RECRUITING

Investigational Site Number : 3000002

Heraklion, 711 10, Greece

RECRUITING

Investigational Site Number : 3480001

Budapest, 1085, Hungary

RECRUITING

Investigational Site Number : 3560005

Hyderabad, 500082, India

RECRUITING

Investigational Site Number : 3560003

Jaipur, 302001, India

RECRUITING

Investigational Site Number : 3560009

Jaipur, 302004, India

RECRUITING

Investigational Site Number : 3560002

Kolkata, 700020, India

RECRUITING

Investigational Site Number : 3560004

Ludhiana, 141002, India

RECRUITING

Investigational Site Number : 3560007

Secunderabad, 500003, India

RECRUITING

Investigational Site Number : 3560001

Surat, 395002, India

ACTIVE NOT RECRUITING

Investigational Site Number : 3560010

Visakhapatnam, 530040, India

RECRUITING

Investigational Site Number : 3800006

Genoa, Genova, 16132, Italy

RECRUITING

Investigational Site Number : 3800002

Milan, Milano, 20132, Italy

RECRUITING

Investigational Site Number : 3800003

Rozzano, Milano, 20089, Italy

RECRUITING

Investigational Site Number : 3800008

Naples, Napoli, 80131, Italy

RECRUITING

Investigational Site Number : 3800001

Padua, Padova, 35128, Italy

RECRUITING

Investigational Site Number : 3800011

Rome, Roma, 00161, Italy

RECRUITING

Investigational Site Number : 3800010

Turin, Torino, 10126, Italy

RECRUITING

Investigational Site Number : 3800007

Alessandria, 15100, Italy

RECRUITING

Investigational Site Number : 3800009

Palermo, 90127, Italy

RECRUITING

Investigational Site Number : 3800004

Pisa, 56124, Italy

RECRUITING

Investigational Site Number : 3920005

Kashiwa, Chiba, 277-0871, Japan

RECRUITING

Investigational Site Number : 3920014

Kure, Hiroshima, 737-0811, Japan

RECRUITING

Investigational Site Number : 3920003

Sapporo, Hokkaido, 004-0041, Japan

RECRUITING

Investigational Site Number : 3920007

Sapporo, Hokkaido, 065-0033, Japan

RECRUITING

Investigational Site Number : 3920009

Yahaba, Iwate, 028-3695, Japan

RECRUITING

Investigational Site Number : 3920013

Yokohama, Kanagawa, 220-0041, Japan

RECRUITING

Investigational Site Number : 3920002

Bunkyo, Tokyo, 113-8510, Japan

RECRUITING

Investigational Site Number : 3920011

Kodaira, Tokyo, 187-8510, Japan

RECRUITING

Investigational Site Number : 3920006

Kofu, Yamanashi, 400-0027, Japan

RECRUITING

Investigational Site Number : 3920012

Hiroshima, 734-0004, Japan

RECRUITING

Investigational Site Number : 3920016

Kagoshima, 892-0843, Japan

RECRUITING

Investigational Site Number : 3920001

Niigata, 950-1104, Japan

RECRUITING

Investigational Site Number : 3920010

Osaka, 530-0011, Japan

COMPLETED

Investigational Site Number : 3920015

Tokyo, 108-8642, Japan

RECRUITING

Investigational Site Number : 6160008

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

RECRUITING

Investigational Site Number : 6160005

Wroclaw, Lower Silesian Voivodeship, 50-750, Poland

RECRUITING

Investigational Site Number : 6160004

Warsaw, Masovian Voivodeship, 03-580, Poland

RECRUITING

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 04-501, Poland

RECRUITING

Investigational Site Number : 6160002

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

RECRUITING

Investigational Site Number : 7100002

Cape Town, 7405, South Africa

RECRUITING

Investigational Site Number : 7100001

Cape Town, 7708, South Africa

RECRUITING

Investigational Site Number : 7100004

KwaDukuza, 4449, South Africa

RECRUITING

Investigational Site Number : 7100003

Pretoria, 0002, South Africa

RECRUITING

Investigational Site Number : 7100005

Pretoria, 0157, South Africa

RECRUITING

Investigational Site Number : 7920002

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920003

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920001

Mersin, 33070, Turkey (Türkiye)

RECRUITING

Related Links

• DRI17822 Plain Language Results Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): July 29, 2027
• Study Completion (Estimated): May 11, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

HU (1); ZA (5); BR (2); US (19); CL (3); BE (2); BU (3); PL (5); AU (1); FR (3); CZ (2); TU (3); CA (3); GR (3); IN (8); CN (10); IT (10); DE (7); AR (5); GE (3); JP (14)