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Recruiting Phase 2 NCT06958536

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

Phase 2 – studying effectiveness and dosage
Conditions: Crohn's Disease

Sponsor: Sanofi

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 12
Australia (1)
Investigational Site Number: 0360002
Brisbane , Queensland
Belgium (1)
Investigational Site Number: 0560001
Leuven
China (1)
Investigative Site: 1560003
Changsha
Czech Republic (1)
Investigational Site Number: 2030002
Brno , JM
France (1)
Investigational Site Number: 2500001
Montpellier
Germany (1)
Investigational Site Number: 2760002
Minden , Northwest
Japan (1)
Investigational Site Number: 3920007
Kashiwa , Chiba
Poland (1)
Investigational Site Number: 6160002
Wroclaw , Lower Silesian Voivodeship
South Africa (1)
Investigational Site Number: 7100003
Johannesburg
Spain (1)
Investigational Site Number: 7240002
Madrid
United Kingdom (1)
Investigational Site Number: 8260007
Bury
United States (1)
Investigational Site Number: 8400024
Tucson , Arizona
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
03.06.2025
Completion date
17.10.2029
Registry ID
NCT06958536
Source
anzctr
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