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A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
NCT06975722 · Sanofi
In plain English
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Official title
A Phase 2b, Multi-national, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Followed by a Long-term Extension to Evaluate the Efficacy and Safety of SAR442970 in Adult Participants With Moderate to Severe Ulcerative Colitis
About this study
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
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 had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
* Must have 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, mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a minimum disease extent of 15 cm from the anal verge
* Must have received prior treatment for UC (either "a" or "b" below or combination of both):
1. History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC
2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat 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 Crohn's Disease (CD), indeterminate colitis or microscopic colitis
* Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools
* Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study
* Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma
* Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition
* History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis (TB) regimen
* Known history of or suspected significant current immunosuppression.
* History or solid organ transplant or splenectomy
* History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident.
* History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
* Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin
* Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.)
* History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening
* History of Interstitial Lung Disease
* Participants with any of the following results at Screening:
* Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
* Positive total Hepatitis B core antibody (anti-HBc) confirmed by positive Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or,
* Positive Hepatitis C Virus (HCV) antibody
* Screening laboratory and other analyses showing abnormal results
* History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
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: 99 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-07-07
Estimated completion: 2029-10-17
Last updated: 2026-03-27
Interventions
Drug: SAR442970Drug: Placebo
Primary outcomes
- • Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS) (At Week 16)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (66)
Investigational Site Number: 8400009Recruiting
Escondido, California, United States
Investigational Site Number: 8400006Recruiting
Lancaster, California, United States
Investigational Site Number: 8400025Recruiting
Thousand Oaks, California, United States
Investigational Site Number: 8400024Recruiting
Jacksonville, Florida, United States
Investigational Site Number: 8400030Recruiting
Kissimmee, Florida, United States
Investigational Site Number: 8400003Recruiting
Lighthouse PT, Florida, United States
Investigational Site Number: 8400001Recruiting
Miami, Florida, United States
Investigational Site Number: 8400011Recruiting
Miami, Florida, United States
Investigational Site Number: 8400010Recruiting
Palmetto Bay, Florida, United States
Investigational Site Number: 8400019Recruiting
Tampa, Florida, United States
Investigational Site Number: 8400018Recruiting
Marietta, Georgia, United States
Investigational Site Number: 8400005Recruiting
Iowa City, Iowa, United States
Investigational Site Number: 8400017Recruiting
Boston, Massachusetts, United States
Investigational Site Number: 8400012Recruiting
Wyoming, Michigan, United States
Investigational Site Number: 8400014Recruiting
St Louis, Missouri, United States
Investigational Site Number: 8400021Recruiting
New York, New York, United States
Investigational Site Number: 8400029Recruiting
Queens Village, New York, United States
Investigational Site Number: 8400002Recruiting
Chapel Hill, North Carolina, United States
Investigational Site Number: 8400013Recruiting
Harrisburg, Pennsylvania, United States
Investigational Site Number: 8400023Recruiting
Houston, Texas, United States
Investigational Site Number: 8400007Recruiting
Ogden, Utah, United States
Investigational Site Number: 0360003Recruiting
Brisbane, Queensland, Australia
Investigational Site Number: 0360001Recruiting
Clayton, Victoria, Australia
Investigational Site Number: 1560004Recruiting
Huizhou, Ghangdong, China
Investigational Site Number: 1560005Recruiting
Guangzhou, Guangdong, China
Investigational Site Number: 1560002Recruiting
Nanjing, Jiangsu, China
Investigational Site Number: 1560008Recruiting
Suzhou, Jiangsu, China
Investigational Site Number: 1560003Recruiting
Wuxi, Jiangsu, China
Investigational Site Number: 1560001Recruiting
Hangzhou, China
Investigational Site Number: 1560007Recruiting
Ningbo, China
Investigational Site Number: 2030001Recruiting
Brno, JM, Czechia
Investigational Site Number: 2030002Recruiting
Slaný, Czechia
Investigational Site Number: 2500002Recruiting
Lille, France
Investigative Site: 2500006Recruiting
Nice, France
Investigational Site Number: 2500005Recruiting
Pierre-Bénite, France
Investigational Site Number: 2500001Recruiting
Saint-Priest-en-Jarez, France
Investigational Site Number: 2500003Recruiting
Toulouse, France
Investigational Site Number: 2500004Withdrawn
Vandœuvre-lès-Nancy, France
Investigational Site Number: 2760001Recruiting
Minden, Northwest, Germany
Investigational Site Number: 2760005Recruiting
Kiel, Schleswig-Holstein, Germany
Investigational Site Number: 2760003Recruiting
Ulm, Germany
Investigational Site Number: 3480003Recruiting
Budapest, Hungary
Investigational Site Number: 3480002Recruiting
Budapest, Hungary
Investigational Site Number: 3480001Recruiting
Vác, Hungary
Investigational Site Number: 3920002Recruiting
Kashiwa, Chiba, Japan
Investigational Site Number: 3920006Recruiting
Ōita, Oita Prefecture, Japan
Investigational Site Number: 3920005Recruiting
Hamamatsu, Japan
Investigational Site Number: 3920003Recruiting
Hirosaki, Japan
Investigational Site Number: 3920001Recruiting
Morioka, Japan
Investigational Site Number: 3920004Recruiting
Nishinomiya, Japan
Investigational Site Number: 4980001Recruiting
Chisinau, Moldova
Investigational Site Number: 6160006Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number: 6160002Recruiting
Bydgoszcz, Poland
Investigational Site Number: 6160009Recruiting
Chojnice, Poland
Investigational Site Number: 6160007Recruiting
Katowice, Poland
Investigational Site Number: 6160005Recruiting
Sopot, Poland
Investigational Site Number: 6160008Recruiting
Tychy, Poland
Investigational Site Number: 6160004Recruiting
Warsaw, Poland
Investigational Site Number: 6160003Recruiting
Warsaw, Poland
Investigational Site Number: 6160001Recruiting
Wroclaw, Poland
Investigational Site Number: 7240001Recruiting
Las Palmas de Gran Canaria, Spain
Investigational Site Number: 7240002Recruiting
Madrid, Spain
Investigational Site Number: 8260002Recruiting
Northwich, CHW, United Kingdom
Investigational Site Number: 8260003Recruiting
Bury, United Kingdom
Investigational Site Number: 8260001Recruiting
London, United Kingdom
Investigational Site Number: 8260004Recruiting
London, United Kingdom