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Recruiting Phase 2 NCT06975722

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

Phase 2 – studying effectiveness and dosage
Conditions: Ulcerative Colitis

Sponsor: Sanofi

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
SAR442970
DRUG
Placebo
DRUG
Locations 67
Australia (2)
Investigational Site Number: 0360003
Brisbane , Queensland
Investigational Site Number: 0360001
Clayton , Victoria
China (8)
Investigational Site Number: 1560005
Guangzhou , Guangdong
Investigational Site Number: 1560001
Hangzhou
Investigational Site Number: 1560004
Huizhou , Ghangdong
Investigational Site Number: 1560002
Nanjing , Jiangsu
Investigational Site Number: 1560007
Ningbo
Investigational Site Number: 1560009
Shanghai , Shanghai Municipality
Investigational Site Number: 1560008
Suzhou , Jiangsu
Investigational Site Number: 1560003
Wuxi , Jiangsu
Czech Republic (2)
Investigational Site Number: 2030001
Brno , JM
Investigational Site Number: 2030002
Slaný
France (6)
Investigational Site Number: 2500002
Lille
Investigative Site: 2500006
Nice
Investigational Site Number: 2500005
Pierre-Bénite
Investigational Site Number: 2500001
Saint-Priest-en-Jarez
Investigational Site Number: 2500003
Toulouse
Investigational Site Number: 2500004
Vandœuvre-lès-Nancy
WITHDRAWN
Germany (3)
Investigational Site Number: 2760005
Kiel , Schleswig-Holstein
Investigational Site Number: 2760001
Minden , Northwest
Investigational Site Number: 2760003
Ulm
Hungary (3)
Investigational Site Number: 3480003
Budapest
Investigational Site Number: 3480002
Budapest
Investigational Site Number: 3480001
Vác
Japan (6)
Investigational Site Number: 3920005
Hamamatsu
Investigational Site Number: 3920003
Hirosaki
Investigational Site Number: 3920002
Kashiwa , Chiba
Investigational Site Number: 3920001
Morioka
Investigational Site Number: 3920004
Nishinomiya
Investigational Site Number: 3920006
Ōita , Oita Prefecture
Moldova (1)
Investigational Site Number: 4980001
Chisinau
Poland (9)
Investigational Site Number: 6160002
Bydgoszcz
Investigational Site Number: 6160009
Chojnice
Investigational Site Number: 6160007
Katowice
Investigational Site Number: 6160005
Sopot
Investigational Site Number: 6160008
Tychy
Investigational Site Number: 6160004
Warsaw
Investigational Site Number: 6160003
Warsaw
Investigational Site Number: 6160006
Wroclaw , Lower Silesian Voivodeship
Investigational Site Number: 6160001
Wroclaw
Spain (2)
Investigational Site Number: 7240001
Las Palmas de Gran Canaria
Investigational Site Number: 7240002
Madrid
United Kingdom (4)
Investigational Site Number: 8260003
Bury
Investigational Site Number: 8260001
London
Investigational Site Number: 8260004
London
Investigational Site Number: 8260002
Northwich , CHW
United States (21)
Investigational Site Number: 8400017
Boston , Massachusetts
Investigational Site Number: 8400002
Chapel Hill , North Carolina
Investigational Site Number: 8400009
Escondido , California
Investigational Site Number: 8400013
Harrisburg , Pennsylvania
Investigational Site Number: 8400023
Houston , Texas
Investigational Site Number: 8400005
Iowa City , Iowa
Investigational Site Number: 8400024
Jacksonville , Florida
Investigational Site Number: 8400030
Kissimmee , Florida
Investigational Site Number: 8400006
Lancaster , California
Investigational Site Number: 8400003
Lighthouse PT , Florida
Investigational Site Number: 8400018
Marietta , Georgia
Investigational Site Number: 8400001
Miami , Florida
Investigational Site Number: 8400011
Miami , Florida
Investigational Site Number: 8400021
New York , New York
Investigational Site Number: 8400007
Ogden , Utah
Investigational Site Number: 8400010
Palmetto Bay , Florida
Investigational Site Number: 8400029
Queens Village , New York
Investigational Site Number: 8400014
St Louis , Missouri
Investigational Site Number: 8400019
Tampa , Florida
Investigational Site Number: 8400025
Thousand Oaks , California
Investigational Site Number: 8400012
Wyoming , Michigan
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
07.07.2025
Completion date
17.10.2029
Registry ID
NCT06975722
Source
clinicaltrials.gov
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