A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
NCT ID: NCT06958536
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
99 participants
INTERVENTIONAL
2025-06-03
2029-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR442970 Dose Regimen A
Participants will receive SAR442970 dose regimen A
SAR442970
Route of Administration: Subcutaneous
SAR442970 Dose Regimen B
Participants will receive SAR442970 dose regimen B
SAR442970
Route of Administration: Subcutaneous
Placebo
Participants will receive placebo
Placebo
Route of Administration: Subcutaneous
Interventions
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SAR442970
Route of Administration: Subcutaneous
Placebo
Route of Administration: Subcutaneous
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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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: 8400012
Miami, 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: 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: 8400002
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
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: 2030002
Brno, JM, Czechia
Investigational Site Number: 2030003
Hradec Králové, , Czechia
Investigational Site Number: 2500001
Montpellier, , France
Investigative Site: 2500003
Nice, , France
Investigational Site Number: 2500002
Toulouse, , France
Investigational Site Number: 2760002
Minden, Northwest, Germany
Investigational Site Number: 2760004
Kiel, , 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: 7240002
Madrid, , Spain
Investigative Site: 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
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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DRI18450 Plain Language Results Summary
Other Identifiers
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U1111-1306-7510
Identifier Type: OTHER
Identifier Source: secondary_id
2024-517016-30-00
Identifier Type: CTIS
Identifier Source: secondary_id
DRI18450
Identifier Type: OTHER
Identifier Source: secondary_id
DRI18450
Identifier Type: -
Identifier Source: org_study_id
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