A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
NCT ID: NCT06975722
Last Updated: 2026-01-23
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
99 participants
INTERVENTIONAL
2025-07-07
2029-10-17
Brief Summary
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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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SAR442970 Dose Regimen A
Participants will receive SAR442970 dose regimen A
SAR442970
Route of administration: Subcutaneous
SAR442970 Dose Regimen B
Participants will receive SAR442970 dose regimen B
SAR442970
Route of administration: Subcutaneous
Placebo
Route of administration: Subcutaneous
Placebo
Participants will receive SAR442970-matching placebo
Placebo
Route of administration: Subcutaneous
Interventions
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SAR442970
Route of administration: Subcutaneous
Placebo
Route of administration: Subcutaneous
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 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number: 8400009
Escondido, California, United States
Investigational Site Number: 8400006
Lancaster, California, United States
Investigational Site Number: 8400025
Thousand Oaks, California, United States
Investigational Site Number: 8400024
Jacksonville, Florida, United States
Investigational Site Number: 8400030
Kissimmee, Florida, United States
Investigational Site Number: 8400003
Lighthouse PT, Florida, United States
Investigational Site Number: 8400001
Miami, Florida, United States
Investigational Site Number: 8400011
Miami, Florida, United States
Investigational Site Number: 8400010
Palmetto Bay, Florida, United States
Investigational Site Number: 8400019
Tampa, Florida, United States
Investigational Site Number: 8400018
Marietta, Georgia, United States
Investigational Site Number: 8400005
Iowa City, Iowa, United States
Investigational Site: 8400017
Boston, Massachusetts, United States
Investigational Site Number: 8400012
Wyoming, Michigan, United States
Investigational Site Number: 8400014
St Louis, Missouri, United States
Investigational Site Number: 8400021
New York, New York, United States
Investigational Site Number: 8400029
Queens Village, New York, United States
Investigational Site Number: 8400002
Chapel Hill, North Carolina, United States
Investigational Site Number: 8400013
Harrisburg, Pennsylvania, United States
Investigational Site Number: 8400023
Houston, Texas, United States
Investigational Site Number: 8400007
Ogden, Utah, United States
Investigational Site Number: 0360003
Brisbane, Queensland, Australia
Investigative Site: 1560005
Guangzhou, Guangdong, China
Investigative Site: 1560002
Nanjing, Jiangsu, China
Investigative Site: 1560008
Suzhou, Jiangsu, China
Investigative Site: 1560003
Wuxi, Jiangsu, China
Investigational Site Number: 1560001
Hangzhou, , China
Investigational Site Number: 1560007
Ningbo, , China
Investigational Site Number: 2030001
Brno, JM, Czechia
Investigational Site Number: 2500002
Lille, , France
Investigative Site: 2500006
Nice, , France
Investigational Site Number: 2500005
Pierre-Bénite, , France
Investigational Site Number: 2500001
Saint-Priest-en-Jarez, , France
Investigational Site Number: 2500003
Toulouse, , France
Investigational Site Number: 2500004
Vandœuvre-lès-Nancy, , France
Investigational Site Number: 2760001
Minden, Northwest, Germany
Investigational Site Number: 2760005
Kiel, Schleswig-Holstein, Germany
Investigational Site Number: 3480003
Budapest, , Hungary
Investigative Site: 3480002
Budapest, , Hungary
Investigational Site Number: 3480001
Vác, , Hungary
Investigational Site Number: 3920002
Kashiwa, Chiba, Japan
Investigational Site Number: 3920006
Ōita, Oita Prefecture, Japan
Investigational Site Number: 3920005
Hamamatsu, , Japan
Investigational Site Number: 3920003
Hirosaki, , Japan
Investigational Site Number: 3920001
Morioka, , Japan
Investigational Site Number: 3920004
Nishinomiya, , Japan
Investigational Site Number: 4980001
Chisinau, , Moldova
Investigational Site Number: 6160006
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number: 6160002
Bydgoszcz, , Poland
Investigational Site Number: 6160009
Chojnice, , Poland
Investigational Site Number: 6160007
Katowice, , Poland
Investigational Site Number: 6160005
Sopot, , Poland
Investigative Site: 6160008
Tychy, , Poland
Investigational Site Number: 6160004
Warsaw, , Poland
Investigational Site Number: 6160003
Warsaw, , Poland
Investigational Site Number: 6160001
Wroclaw, , Poland
Investigational Site Number: 7240001
Las Palmas de Gran Canaria, , Spain
Investigational Site Number: 7240002
Madrid, , Spain
Investigational Site Number: 8260002
Northwich, CHW, United Kingdom
Investigational Site Number: 8260003
Bury, , United Kingdom
Investigational Site Number: 8260001
London, , United Kingdom
Investigational Site Number: 8260004
London, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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ACT18134 Plain Language Results Summary
Other Identifiers
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2024-515241-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1305-7281
Identifier Type: OTHER
Identifier Source: secondary_id
ACT18134
Identifier Type: OTHER
Identifier Source: secondary_id
ACT18134
Identifier Type: -
Identifier Source: org_study_id
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