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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

∙ 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):

‣ 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

⁃ 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

Locations
United States
California
Gastroenterology & Liver Institute - Site Number: 8400009
RECRUITING
Escondido
Gastro Care Institute - Site Number: 8400006
RECRUITING
Lancaster
Clinical Trials Management Services, LLC
RECRUITING
Thousand Oaks
Florida
Green Leaf Clinical Trials - Site Number: 8400024
RECRUITING
Jacksonville
Alliance Medical Research LLC - Site Number: 8400003
RECRUITING
Lighthouse Pt
Research Associates of South Florida, LLC - Site Number: 8400001
RECRUITING
Miami
Tropical Clinical Trials - Site Number: 8400010
RECRUITING
Palmetto Bay
Georgia
Gastrointestinal Specialists of Georgia, PC - Site Number: 8400018
RECRUITING
Marietta
Iowa
University of Iowa Hospitals and Clinics - Site Number: 8400005
RECRUITING
Iowa City
Michigan
Gastroenterology Associates of Western Michigan - Site Number: 8400012
RECRUITING
Wyoming
Pennsylvania
Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400013
RECRUITING
Harrisburg
Utah
Advanced Research Institute - Site Number: 8400007
RECRUITING
Ogden
Other Locations
Australia
Mater Misericordiae Limited - Site Number: 0360003
RECRUITING
Brisbane
France
Centre Hospitalier Lyon-Sud - Site Number: 2500005
RECRUITING
Pierre-bénite
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2029-10-17
Participants
Target number of participants: 99
Treatments
Experimental: SAR442970 Dose Regimen A
Participants will receive SAR442970 dose regimen A
Experimental: SAR442970 Dose Regimen B
Participants will receive SAR442970 dose regimen B
Placebo_comparator: Placebo
Participants will receive SAR442970-matching placebo
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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