A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
NCT ID: NCT06637631
Last Updated: 2025-11-14
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
260 participants
INTERVENTIONAL
2024-12-10
2029-05-23
Brief Summary
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This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance.
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.
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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SAR441566 dose 1
Participants will receive SAR441566 dose 1.
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 dose 2
Participants will receive SAR441566 dose 2.
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 dose 3
Participants will receive SAR441566 dose 3.
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Participants will receive SAR441566 matching placebo.
SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Interventions
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SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Eligibility Criteria
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Inclusion Criteria
1. Male or female participants aged 18 to 75 years at the time of signing the ICF
2. Confirmed diagnosis of CD for at least 3 months prior to Baseline
3. Confirmed diagnosis of moderate to severe CD as assessed by:
* Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
* stool frequency (SF), abdominal pain (AP) score
4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
5. On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX ..)
6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.
Exclusion Criteria
1. Participants with active UC, indeterminate colitis or short bowel syndrome
2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3 bowel resections
4. Participants with stool sample positive for infectious pathogens
5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
14. Participants who received fecal microbial transplantation within 30 days prior to screening
15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
18. Screening laboratory and other analyses show abnormal results
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
Sun City, Arizona, United States
Bristol Hospital- Site Number : 8400007
Bristol, Connecticut, United States
Novum Research- Site Number : 8400021
Clermont, Florida, United States
Homestead Associates in Research- Site Number : 8400012
Homestead, Florida, United States
Clinical Research of Osceola- Site Number : 8400013
Kissimmee, Florida, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
Miami Lakes, Florida, United States
GCP Clinical Research- Site Number : 8400004
Tampa, Florida, United States
GI Alliance - Glenview- Site Number : 8400015
Glenview, Illinois, United States
Illinois Gastroenterology Group- Site Number : 8400011
Gurnee, Illinois, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400017
Ann Arbor, Michigan, United States
GI Alliance - Flowood- Site Number : 8400019
Flowood, Mississippi, United States
Vector Clinical Trials- Site Number : 8400001
Las Vegas, Nevada, United States
Queens Village Primary Medical Center- Site Number : 8400005
Queens Village, New York, United States
Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
Greenville, North Carolina, United States
Frontier Clinical Research - Uniontown- Site Number : 8400009
Uniontown, Pennsylvania, United States
Gastro Health & Nutrition- Site Number : 8400003
Katy, Texas, United States
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
Southlake, Texas, United States
Washington Gastroenterology - Tacoma- Site Number : 8400008
Tacoma, Washington, United States
Investigational Site Number : 0320002
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320003
Buenos Aires, , Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320006
Buenos Aires, , Argentina
Investigational Site Number : 0360002
Sydney, New South Wales, Australia
Investigational Site Number : 0360001
South Brisbane, Queensland, Australia
Investigational Site Number : 0360003
Parkville, Victoria, Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
Salvador, Estado de Bahia, Brazil
Hospital Moinhos de Vento- Site Number : 0760006
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
Pesquisare Saude- Site Number : 0760004
Santo André, São Paulo, Brazil
Investigational Site Number : 1000001
Gorna Oryahovitsa, , Bulgaria
Investigational Site Number : 1240001
Calgary, Alberta, Canada
Investigational Site Number : 1240003
Montreal, Quebec, Canada
Investigational Site Number : 1240005
Québec, Quebec, Canada
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520006
Concepción, Región del Biobío, Chile
Investigational Site Number : 1520004
Talcahuano, Región del Biobío, Chile
Investigational Site Number : 1560008
Changzhou, , China
Investigational Site Number : 1560009
Chongqing, , China
Investigational Site Number : 1560012
Fuzhou, , China
Investigational Site Number : 1560001
Guangzhou, , China
Investigational Site Number : 1560002
Guangzhou, , China
Investigational Site Number : 1560004
Hangzhou, , China
Investigational Site Number : 1560003
Hangzhou, , China
Investigational Site Number : 1560007
Hefei, , China
Investigational Site Number : 1560011
Nanchang, , China
Investigational Site Number : 1560006
Shanghai, , China
Investigational Site Number : 1560005
Shanghai, , China
Investigational Site Number : 1560010
Suzhou, , China
Investigational Site Number : 1910004
Osijek, , Croatia
Investigational Site Number : 2030004
Hradec Králové, , Czechia
Investigational Site Number : 2030001
Olomouc, , Czechia
Investigational Site Number : 2500005
Montpellier, , France
Investigational Site Number : 2500002
Nice, , France
Investigational Site Number : 2500004
Saint-Priest-en-Jarez, , France
Investigational Site Number : 2500001
Vandœuvre-lès-Nancy, , France
Investigational Site Number : 2680006
Kutaisi, , Georgia
Investigational Site Number : 2680007
Tbilisi, , Georgia
Investigational Site Number : 2680001
Tbilisi, , Georgia
Investigational Site Number : 2680005
Tbilisi, , Georgia
Investigational Site Number : 2680002
Tbilisi, , Georgia
Investigational Site Number : 2680003
Tbilisi, , Georgia
Investigational Site Number : 2680004
Tbilisi, , Georgia
Investigational Site Number : 2760004
Berlin, , Germany
Investigational Site Number : 2760002
Berlin, , Germany
Investigational Site Number : 2760005
Halle, , Germany
Investigational Site Number : 3480006
Szekszárd, , Hungary
Investigational Site Number : 3480004
Tatabánya, , Hungary
Investigational Site Number : 3560007
Hyderabad, , India
Investigational Site Number : 3560003
Hyderabad, , India
Investigational Site Number : 3560009
Jaipur, , India
Investigational Site Number : 3560001
Jaipur, , India
Investigational Site Number : 3560002
Secunderabad, , India
Investigational Site Number : 3560013
Surat, , India
Investigational Site Number : 3560010
Surat, , India
Investigational Site Number : 3800009
Milan, Milano, Italy
Investigational Site Number : 3800002
Milan, Milano, Italy
Investigational Site Number : 3800004
Rozzano, Milano, Italy
Investigational Site Number : 3800001
Padua, Padova, Italy
Investigational Site Number : 3800008
Rome, Roma, Italy
Investigational Site Number : 3800006
Rome, Roma, Italy
Investigational Site Number : 3800005
Pisa, , Italy
Investigational Site Number : 3920004
Kashiwa, Chiba, Japan
Investigational Site Number : 3920001
Sakura, Chiba, Japan
Investigational Site Number : 3920005
Kitakyushu, Fukuoka, Japan
Investigational Site Number : 3920006
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920010
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920007
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920008
Morioka, Iwate, Japan
Investigational Site Number : 3920019
Takamatsu, Kagawa-ken, Japan
Investigational Site Number : 3920020
Nagaoka, Niigata, Japan
Investigational Site Number : 3920003
Bunkyo, Tokyo, Japan
Investigational Site Number : 3920013
Hiroshima, , Japan
Investigational Site Number : 3920002
Osaka, , Japan
Investigational Site Number : 3920018
Ōita, , Japan
Investigational Site Number : 3920011
Tokyo, , Japan
Investigational Site Number : 3920012
Wakayama, , Japan
Investigational Site Number : 4800001
Vacoas, , Mauritius
Investigational Site Number : 5280004
Breda, , Netherlands
Investigational Site Number : 5280002
Nijmegen, , Netherlands
Investigational Site Number : 5280001
Tilburg, , Netherlands
Investigational Site Number : 5280003
Utrecht, , Netherlands
Investigational Site Number : 6160005
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160006
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002
Sopot, Pomeranian Voivodeship, Poland
Investigational Site Number : 6420004
Bucharest, , Romania
Investigational Site Number : 6420003
Constanța, , Romania
Investigational Site Number : 4100002
Haeundae-gu, Busan, South Korea
Investigational Site Number : 4100001
Daegu, Daegu, South Korea
Investigational Site Number : 4100003
Daejeon, Daejeon, South Korea
Investigational Site Number : 7240002
Seville, Sevilla, Spain
Investigational Site Number : 7240001
Madrid, , Spain
Investigational Site Number : 7920003
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, , Turkey (Türkiye)
Investigational Site Number : 7920002
Zonguldak, , Turkey (Türkiye)
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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DRI18212 Plain Language Results Summary
Other Identifiers
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2024-512633-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1301-3830
Identifier Type: OTHER
Identifier Source: secondary_id
DRI18212
Identifier Type: -
Identifier Source: org_study_id