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Clinical Trials in the UK / NCT06958536
Recruiting Phase 2

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

NCT06958536 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2025-06-03
Last updated
2026-03-27

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

SAR442970Placebo

SAR442970: Route of Administration: Subcutaneous

Placebo: Route of Administration: Subcutaneous

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening * Confirmed diagnosis of moderate-to-severe CD * History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies * On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.) * 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 with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome * Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement * Participants with following ongoing known complications of CD: * Any manifestation that might require bowel surgery while enrolled in the study * Participant with ostomy or ileoanal pouch * Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome * Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections * History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcome measure(s)

Trial sites (66)

FacilityCityRegionStatus
Investigational Site Number: 8400024 Tucson Arizona Recruiting
Investigational Site Number: 8400005 Escondido California Recruiting
Investigational Site Number: 8400001 Lancaster California Recruiting
Investigational Site Number: 8400017 Kissimmee Florida Recruiting
Investigational Site Number: 8400015 Lighthouse PT Florida Recruiting
Investigational Site Number 8400028 Miami Florida Recruiting
Investigational Site Number: 8400012 Miami Florida Recruiting
Investigational Site Number: 8400007 Orlando Florida Recruiting
Investigational Site Number: 8400011 Palmetto Bay Florida Recruiting
Investigational Site Number: 8400019 Marietta Georgia Recruiting
Investigational Site Number: 8400025 Iowa City Iowa Recruiting
Investigational Site Number: 8400006 Kansas City Kansas Recruiting
Investigational Site Number: 8400022 Boston Massachusetts Recruiting
Investigational Site Number: 8400008 Wyoming Michigan Recruiting
Investigational Site Number: 8400013 St Louis Missouri Recruiting
Investigational Site Number: 8400003 Chapel Hill North Carolina Recruiting
Investigational Site Number: 8400009 Harrisburg Pennsylvania Recruiting
Investigational Site Number: 8400002 Fredericksburg Texas Recruiting
Investigational Site Number: 8400016 Ogden Utah Recruiting
Investigational Site Number: 8400027 Richmond Virginia Recruiting
Investigational Site Number: 0360002 Brisbane Queensland Recruiting
Investigational Site Number: 0360004 Kurralta Park South Australia Recruiting
Investigational Site Number: 0360001 Footscray Australia Recruiting
Investigational Site Number: 0560001 Leuven Belgium Recruiting
Investigative Site: 1560003 Changsha China Recruiting
Investigational Site Number: 1560008 Changsha China Recruiting
Investigative Site: 1560005 Changzhou China Recruiting
Investigational Site Number: 1560001 Guangzhou China Recruiting
Investigational Site Number: 1560006 Hangzhou China Recruiting
Investigative Site: 1560004 Nanchang China Recruiting
Investigative Site: 1560002 Shanghai China Recruiting
Investigational Site Number: 1560007 Shenyang China Recruiting
Investigational Site Number: 2030002 Brno JM Recruiting
Investigational Site Number: 2030003 Hradec Králové Czechia Recruiting
Investigational Site Number: 2030005 Slaný Czechia Recruiting
Investigational Site Number: 2500001 Montpellier France Recruiting
Investigational Site Number: 2500003 Nice France Recruiting
Investigational Site Number: 2500002 Toulouse France Recruiting
Investigational Site Number: 2760002 Minden Northwest Recruiting
Investigational Site Number: 2760003 Jena Germany Recruiting

+ 26 more sites — see the full list on the official registry below.

More Sanofi trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT06958536 on ClinicalTrials.gov ↗ ← All trials in the UK