RecruitingPhase 2NCT06958536

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease


Sponsor

Sanofi

Enrollment

99 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. 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 Crohn's disease. 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 in people with moderate-to-severe Crohn's disease who have not responded well to — or cannot tolerate — existing treatments. Crohn's disease is a chronic inflammatory bowel condition that can cause severe abdominal pain, diarrhea, and complications. **You may be eligible if...** - You have had Crohn's disease for at least 3 months - Your Crohn's disease is moderate to severe - You have tried standard treatments (such as steroids, immune suppressants, or biologics) but they haven't worked well enough, have stopped working, or caused intolerable side effects - You are on a stable dose of any current Crohn's medication - You are using appropriate contraception if required **You may NOT be eligible if...** - You have a current serious infection, including active tuberculosis - You have had certain bowel surgeries recently - You have other major health conditions that could interfere with the study - You are pregnant or planning to become pregnant 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.

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Interventions

DRUGSAR442970

Route of Administration: Subcutaneous

DRUGPlacebo

Route of Administration: Subcutaneous


Locations(66)

Investigational Site Number: 8400024

Tucson, Arizona, United States

Investigational Site Number: 8400005

Escondido, California, United States

Investigational Site Number: 8400001

Lancaster, California, United States

Investigational Site Number: 8400017

Kissimmee, Florida, United States

Investigational Site Number: 8400015

Lighthouse PT, Florida, United States

Investigational Site Number 8400028

Miami, Florida, United States

Investigational Site Number: 8400012

Miami, Florida, United States

Investigational Site Number: 8400007

Orlando, Florida, United States

Investigational Site Number: 8400011

Palmetto Bay, Florida, United States

Investigational Site Number: 8400019

Marietta, Georgia, United States

Investigational Site Number: 8400025

Iowa City, Iowa, United States

Investigational Site Number: 8400006

Kansas City, Kansas, United States

Investigational Site Number: 8400022

Boston, Massachusetts, United States

Investigational Site Number: 8400008

Wyoming, Michigan, United States

Investigational Site Number: 8400013

St Louis, Missouri, United States

Investigational Site Number: 8400003

Chapel Hill, North Carolina, United States

Investigational Site Number: 8400009

Harrisburg, Pennsylvania, United States

Investigational Site Number: 8400002

Fredericksburg, Texas, United States

Investigational Site Number: 8400016

Ogden, Utah, United States

Investigational Site Number: 8400027

Richmond, Virginia, United States

Investigational Site Number: 0360002

Brisbane, Queensland, Australia

Investigational Site Number: 0360004

Kurralta Park, South Australia, Australia

Investigational Site Number: 0360001

Footscray, Australia

Investigational Site Number: 0560001

Leuven, Belgium

Investigative Site: 1560003

Changsha, China

Investigational Site Number: 1560008

Changsha, China

Investigative Site: 1560005

Changzhou, China

Investigational Site Number: 1560001

Guangzhou, China

Investigational Site Number: 1560006

Hangzhou, China

Investigative Site: 1560004

Nanchang, China

Investigative Site: 1560002

Shanghai, China

Investigational Site Number: 1560007

Shenyang, China

Investigational Site Number: 2030002

Brno, JM, Czechia

Investigational Site Number: 2030003

Hradec Králové, Czechia

Investigational Site Number: 2030005

Slaný, Czechia

Investigational Site Number: 2500001

Montpellier, France

Investigational Site Number: 2500003

Nice, France

Investigational Site Number: 2500002

Toulouse, France

Investigational Site Number: 2760002

Minden, Northwest, Germany

Investigational Site Number: 2760003

Jena, Germany

Investigational Site Number: 2760004

Kiel, Germany

Investigational Site Number: 2760001

Ulm, Germany

Investigational Site Number: 3920007

Kashiwa, Chiba, Japan

Investigational Site Number: 3920005

Ōita, Oita Prefecture, Japan

Investigational Site Number: 3920006

Hamamatsu, Shizuoka, Japan

Investigational Site Number: 3920004

Bunkyō City, Japan

Investigational Site Number: 3920003

Hamamatsu, Japan

Investigational Site Number: 3920009

Hirosaki, Japan

Investigational Site Number: 3920001

Morioka, Japan

Investigational Site Number: 3920002

Nishinomiya, Japan

Investigational Site Number: 6160002

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number: 6160001

Krakow, Poland

Investigational Site Number: 6160005

Lublin, Poland

Investigational Site Number: 6160006

Sopot, Poland

Investigational Site Number: 6160008

Warsaw, Poland

Investigational Site Number: 6160003

Warsaw, Poland

Investigational Site Number: 6160004

Wroclaw, Poland

Investigational Site Number: 7100003

Johannesburg, South Africa

Investigational Site Number: 7240002

Madrid, Spain

Investigational Site Number: 7240001

Madrid, Spain

Investigational Site Number: 7240003

Seville, Spain

Investigational Site Number: 8260007

Bury, United Kingdom

Investigational Site Number: 8260004

Cambridge, United Kingdom

Investigational Site Number: 8260005

London, United Kingdom

Investigational Site Number: 8260002

London, United Kingdom

Investigational Site Number: 8260001

London, United Kingdom

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NCT06958536


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