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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS) — At Week 16 Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Trial sites (67)
Facility
City
Region
Status
Investigational Site Number: 8400009
Escondido
California
Recruiting
Investigational Site Number: 8400006
Lancaster
California
Recruiting
Investigational Site Number: 8400025
Thousand Oaks
California
Recruiting
Investigational Site Number: 8400024
Jacksonville
Florida
Recruiting
Investigational Site Number: 8400030
Kissimmee
Florida
Recruiting
Investigational Site Number: 8400003
Lighthouse PT
Florida
Recruiting
Investigational Site Number: 8400001
Miami
Florida
Recruiting
Investigational Site Number: 8400011
Miami
Florida
Recruiting
Investigational Site Number: 8400010
Palmetto Bay
Florida
Recruiting
Investigational Site Number: 8400019
Tampa
Florida
Recruiting
Investigational Site Number: 8400018
Marietta
Georgia
Recruiting
Investigational Site Number: 8400005
Iowa City
Iowa
Recruiting
Investigational Site Number: 8400017
Boston
Massachusetts
Recruiting
Investigational Site Number: 8400012
Wyoming
Michigan
Recruiting
Investigational Site Number: 8400014
St Louis
Missouri
Recruiting
Investigational Site Number: 8400021
New York
New York
Recruiting
Investigational Site Number: 8400029
Queens Village
New York
Recruiting
Investigational Site Number: 8400002
Chapel Hill
North Carolina
Recruiting
Investigational Site Number: 8400013
Harrisburg
Pennsylvania
Recruiting
Investigational Site Number: 8400023
Houston
Texas
Recruiting
Investigational Site Number: 8400007
Ogden
Utah
Recruiting
Investigational Site Number: 0360003
Brisbane
Queensland
Recruiting
Investigational Site Number: 0360001
Clayton
Victoria
Recruiting
Investigational Site Number: 1560004
Huizhou
Ghangdong
Recruiting
Investigational Site Number: 1560005
Guangzhou
Guangdong
Recruiting
Investigational Site Number: 1560002
Nanjing
Jiangsu
Recruiting
Investigational Site Number: 1560008
Suzhou
Jiangsu
Recruiting
Investigational Site Number: 1560003
Wuxi
Jiangsu
Recruiting
Investigational Site Number: 1560009
Shanghai
Shanghai Municipality
Recruiting
Investigational Site Number: 1560001
Hangzhou
China
Recruiting
Investigational Site Number: 1560007
Ningbo
China
Recruiting
Investigational Site Number: 2030001
Brno
JM
Recruiting
Investigational Site Number: 2030002
Slaný
Czechia
Recruiting
Investigational Site Number: 2500002
Lille
France
Recruiting
Investigative Site: 2500006
Nice
France
Recruiting
Investigational Site Number: 2500005
Pierre-Bénite
France
Recruiting
Investigational Site Number: 2500001
Saint-Priest-en-Jarez
France
Recruiting
Investigational Site Number: 2500003
Toulouse
France
Recruiting
Investigational Site Number: 2500004
Vandœuvre-lès-Nancy
France
Withdrawn
Investigational Site Number: 2760001
Minden
Northwest
Recruiting
+ 27 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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