RecruitingPhase 2NCT06975722

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

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


Sponsor

Sanofi

Enrollment

99 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SAR442970 to see if it can safely and effectively reduce inflammation and improve symptoms in people with moderate-to-severe ulcerative colitis (UC) — a chronic condition where the lining of the large intestine becomes inflamed and ulcerated. **You may be eligible if...** - You are between 18 and 75 years old - You have had UC for at least 3 months with confirmed active inflammation (shown by colonoscopy) - Your UC is currently classified as moderate to severe based on standard scoring - You have had an inadequate response or intolerance to prior UC medications **You may NOT be eligible if...** - You have Crohn's disease or another type of inflammatory bowel disease - You have active serious infections (e.g., tuberculosis, hepatitis) - You have recently used certain biologic medications for UC - You are pregnant or planning to become pregnant - You have significant liver, kidney, or heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSAR442970

Route of administration: Subcutaneous

DRUGPlacebo

Route of administration: Subcutaneous


Locations(67)

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 Number: 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

Investigational Site Number: 0360001

Clayton, Victoria, Australia

Investigational Site Number: 1560004

Huizhou, Ghangdong, China

Investigational Site Number: 1560005

Guangzhou, Guangdong, China

Investigational Site Number: 1560002

Nanjing, Jiangsu, China

Investigational Site Number: 1560008

Suzhou, Jiangsu, China

Investigational Site Number: 1560003

Wuxi, Jiangsu, China

Investigational Site Number: 1560009

Shanghai, Shanghai Municipality, China

Investigational Site Number: 1560001

Hangzhou, China

Investigational Site Number: 1560007

Ningbo, China

Investigational Site Number: 2030001

Brno, JM, Czechia

Investigational Site Number: 2030002

Slaný, 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: 2760003

Ulm, Germany

Investigational Site Number: 3480003

Budapest, Hungary

Investigational Site Number: 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

Investigational Site Number: 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06975722


Related Trials