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 (51) 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
Investigational Site Number: 8400009
RECRUITING
Escondido
Investigational Site Number: 8400006
RECRUITING
Lancaster
Investigational Site Number: 8400025
RECRUITING
Thousand Oaks
Florida
Investigational Site Number: 8400024
RECRUITING
Jacksonville
Investigational Site Number: 8400003
RECRUITING
Lighthouse Pt
Investigational Site Number: 8400001
RECRUITING
Miami
Investigational Site Number: 8400011
RECRUITING
Miami
Investigational Site Number: 8400010
RECRUITING
Palmetto Bay
Investigational Site Number: 8400019
RECRUITING
Tampa
Georgia
Investigational Site Number: 8400018
RECRUITING
Marietta
Iowa
Investigational Site Number: 8400005
RECRUITING
Iowa City
Michigan
Investigational Site Number: 8400012
RECRUITING
Wyoming
Missouri
Investigational Site Number: 8400014
RECRUITING
St Louis
North Carolina
Investigational Site Number: 8400002
RECRUITING
Chapel Hill
New York
Investigational Site Number: 8400021
RECRUITING
New York
Pennsylvania
Investigational Site Number: 8400013
RECRUITING
Harrisburg
Texas
Investigational Site Number: 8400023
RECRUITING
Houston
Utah
Investigational Site Number: 8400007
RECRUITING
Ogden
Other Locations
Australia
Investigational Site Number: 0360003
RECRUITING
Brisbane
China
Investigational Site Number: 1560001
RECRUITING
Hangzhou
Investigational Site Number: 1560007
RECRUITING
Ningbo
France
Investigational Site Number: 2500002
RECRUITING
Lille
Investigational Site Number: 2500005
RECRUITING
Pierre-bénite
Investigational Site Number: 2500001
RECRUITING
Saint-priest-en-jarez
Investigational Site Number: 2500003
RECRUITING
Toulouse
Investigational Site Number: 2500004
RECRUITING
Vandœuvre-lès-nancy
Germany
Investigational Site Number: 2760005
RECRUITING
Kiel
Investigational Site Number: 2760001
RECRUITING
Minden
Hungary
Investigational Site Number: 3480003
RECRUITING
Budapest
Investigational Site Number: 3480001
RECRUITING
Vác
Japan
Investigational Site Number: 3920005
RECRUITING
Hamamatsu
Investigational Site Number: 3920003
RECRUITING
Hirosaki
Investigational Site Number: 3920002
RECRUITING
Kashiwa
Investigational Site Number: 3920001
RECRUITING
Morioka
Investigational Site Number: 3920004
RECRUITING
Nishinomiya
Investigational Site Number: 3920006
RECRUITING
Ōita
Poland
Investigational Site Number: 6160002
RECRUITING
Bydgoszcz
Investigational Site Number: 6160009
RECRUITING
Chojnice
Investigational Site Number: 6160007
RECRUITING
Katowice
Investigational Site Number: 6160005
RECRUITING
Sopot
Investigational Site Number: 6160003
RECRUITING
Warsaw
Investigational Site Number: 6160004
RECRUITING
Warsaw
Investigational Site Number: 6160001
RECRUITING
Wroclaw
Investigational Site Number: 6160006
RECRUITING
Wroclaw
Republic of Moldova
Investigational Site Number: 4980001
RECRUITING
Chisinau
Spain
Investigational Site Number: 7240001
RECRUITING
Las Palmas De Gran Canaria
Investigational Site Number: 7240002
RECRUITING
Madrid
United Kingdom
Investigational Site Number: 8260003
RECRUITING
Bury
Investigational Site Number: 8260001
RECRUITING
London
Investigational Site Number: 8260004
RECRUITING
London
Investigational Site Number: 8260002
RECRUITING
Northwich
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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