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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
NCT06637631 · Sanofi
In plain English
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Official title
A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.
About this study
This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.
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 for participants not enrolling in the Long Term Safety (LTS) study. 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.
Eligibility criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
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, thiopurines (eg. 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:
Participants are excluded from the study if any of the following criteria apply:
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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study design
Enrollment target: 260 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-12-10
Estimated completion: 2029-05-23
Last updated: 2026-03-23
Interventions
Drug: SAR441566Drug: SAR441566 matching Placebo
Primary outcomes
- • Proportion of participants achieving endoscopic response (Week 12)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (135)
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020Recruiting
Sun City, Arizona, United States
Bristol Hospital- Site Number : 8400007Recruiting
Bristol, Connecticut, United States
Novum Research- Site Number : 8400021Recruiting
Clermont, Florida, United States
Homestead Associates in Research- Site Number : 8400012Recruiting
Homestead, Florida, United States
Clinical Research of Osceola- Site Number : 8400013Recruiting
Kissimmee, Florida, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010Recruiting
Miami Lakes, Florida, United States
GCP Clinical Research- Site Number : 8400004Recruiting
Tampa, Florida, United States
GI Alliance - Glenview- Site Number : 8400015Recruiting
Glenview, Illinois, United States
Illinois Gastroenterology Group- Site Number : 8400011Recruiting
Gurnee, Illinois, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400017Recruiting
Ann Arbor, Michigan, United States
GI Alliance - Flowood- Site Number : 8400019Recruiting
Flowood, Mississippi, United States
Vector Clinical Trials- Site Number : 8400001Recruiting
Las Vegas, Nevada, United States
Queens Village Primary Medical Center- Site Number : 8400005Recruiting
Queens Village, New York, United States
Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014Recruiting
Greenville, North Carolina, United States
Frontier Clinical Research - Uniontown- Site Number : 8400009Recruiting
Uniontown, Pennsylvania, United States
Gastro Health & Nutrition- Site Number : 8400003Recruiting
Katy, Texas, United States
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002Recruiting
Southlake, Texas, United States
Washington Gastroenterology - Tacoma- Site Number : 8400008Recruiting
Tacoma, Washington, United States
Investigational Site Number : 0320002Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320003Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320005Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320001Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320004Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320006Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0360002Recruiting
Sydney, New South Wales, Australia
Investigational Site Number : 0360001Recruiting
South Brisbane, Queensland, Australia
Investigational Site Number : 0360003Recruiting
Parkville, Victoria, Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001Recruiting
Salvador, Estado de Bahia, Brazil
Hospital Moinhos de Vento- Site Number : 0760006Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles- Site Number : 0760002Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Pesquisare Saude- Site Number : 0760004Recruiting
Santo André, São Paulo, Brazil
Investigational Site Number : 1000001Recruiting
Gorna Oryahovitsa, Bulgaria
Investigational Site Number : 1000004Recruiting
Sofia, Bulgaria
Investigational Site Number : 1000005Recruiting
Sofia, Bulgaria
Investigational Site Number : 1240001Recruiting
Calgary, Alberta, Canada
Investigational Site Number : 1240003Recruiting
Montreal, Quebec, Canada
Investigational Site Number : 1240005Recruiting
Québec, Quebec, Canada
Investigational Site Number : 1520006Recruiting
Concepción, Biobio, Chile
Investigational Site Number : 1520004Recruiting
Talcahuano, Biobio, Chile
Investigational Site Number : 1520007Recruiting
Temuco, La Araucanía, Chile
Investigational Site Number : 1520001Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002Recruiting
Viña del Mar, Valparaiso, Chile
Investigational Site Number : 1560008Recruiting
Changzhou, China
Investigational Site Number : 1560009Recruiting
Chongqing, China
Investigational Site Number : 1560012Recruiting
Fuzhou, China
Investigational Site Number : 1560001Recruiting
Guangzhou, China
Investigational Site Number : 1560002Recruiting
Guangzhou, China
Investigational Site Number : 1560004Recruiting
Hangzhou, China
Investigational Site Number : 1560003Recruiting
Hangzhou, China
Investigational Site Number : 1560007Recruiting
Hefei, China
Investigational Site Number : 1560011Recruiting
Nanchang, China
Investigational Site Number : 1560006Recruiting
Shanghai, China
Investigational Site Number : 1560005Recruiting
Shanghai, China
Investigational Site Number : 1560010Recruiting
Suzhou, China
Investigational Site Number : 1910004Recruiting
Osijek, Croatia
Investigational Site Number : 1910003Recruiting
Zagreb, Croatia
Investigational Site Number : 2030003Recruiting
Brno, Czechia
Investigational Site Number : 2030002Recruiting
Brno, Czechia
Investigational Site Number : 2030004Recruiting
Hradec Králové, Czechia
Investigational Site Number : 2500005Recruiting
Montpellier, France
Investigational Site Number : 2500002Recruiting
Nice, France
Investigational Site Number : 2500004Recruiting
Saint-Priest-en-Jarez, France
Investigational Site Number : 2500003Recruiting
Toulouse, France
Investigational Site Number : 2500001Recruiting
Vandœuvre-lès-Nancy, France
Investigational Site Number : 2680006Recruiting
Kutaisi, Georgia
Investigational Site Number : 2680007Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680001Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680005Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680002Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680003Recruiting
Tbilisi, Georgia
Investigational Site Number : 2680004Recruiting
Tbilisi, Georgia
Investigational Site Number : 2760004Recruiting
Berlin, Germany
Investigational Site Number : 2760002Recruiting
Berlin, Germany
Investigational Site Number : 2760001Recruiting
Fulda, Germany
Investigational Site Number : 2760005Recruiting
Halle, Germany
Investigational Site Number : 2760006Recruiting
Ludwigshafen, Germany
Investigational Site Number : 3480008Recruiting
Budapest, Hungary
Investigational Site Number : 3480001Recruiting
Gyöngyös, Hungary
Investigational Site Number : 3480009Recruiting
Gyöngyös, Hungary
Investigational Site Number : 3480005Recruiting
Szeged, Hungary
Investigational Site Number : 3480006Recruiting
Szekszárd, Hungary
Investigational Site Number : 3480004Recruiting
Tatabánya, Hungary
Investigational Site Number : 3560007Recruiting
Hyderabad, India
Investigational Site Number : 3560003Recruiting
Hyderabad, India
Investigational Site Number : 3560009Recruiting
Jaipur, India
Investigational Site Number : 3560001Recruiting
Jaipur, India
Investigational Site Number : 3560005Recruiting
Kolkata, India
Investigational Site Number : 3560006Recruiting
Pune, India
Investigational Site Number : 3560002Recruiting
Secunderabad, India
Investigational Site Number : 3560013Recruiting
Surat, India
Investigational Site Number : 3560010Recruiting
Surat, India
Investigational Site Number : 3800009Recruiting
Milan, Milano, Italy
Investigational Site Number : 3800002Recruiting
Milan, Milano, Italy
Investigational Site Number : 3800004Recruiting
Rozzano, Milano, Italy
Investigational Site Number : 3800001Recruiting
Padua, Padova, Italy
Investigational Site Number : 3800008Recruiting
Rome, Roma, Italy
Investigational Site Number : 3800006Recruiting
Rome, Roma, Italy
Investigational Site Number : 3800005Recruiting
Pisa, Italy
Investigational Site Number : 3920004Recruiting
Kashiwa, Chiba, Japan
Investigational Site Number : 3920001Recruiting
Sakura, Chiba, Japan
Investigational Site Number : 3920005Recruiting
Kitakyushu, Fukuoka, Japan
Investigational Site Number : 3920006Recruiting
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920010Recruiting
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920007Recruiting
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920008Recruiting
Yahaba, Iwate, Japan
Investigational Site Number : 3920019Recruiting
Takamatsu, Kagawa-ken, Japan
Investigational Site Number : 3920020Recruiting
Nagaoka, Niigata, Japan
Investigational Site Number : 3920003Recruiting
Bunkyo, Tokyo, Japan
Investigational Site Number : 3920013Recruiting
Hiroshima, Japan
Investigational Site Number : 3920002Recruiting
Osaka, Japan
Investigational Site Number : 3920018Recruiting
Ōita, Japan
Investigational Site Number : 3920011Recruiting
Tokyo, Japan
Investigational Site Number : 3920012Recruiting
Wakayama, Japan
Investigational Site Number : 4800001Recruiting
Vacoas, Mauritius
Investigational Site Number : 5280004Recruiting
Breda, Netherlands
Investigational Site Number : 5280002Recruiting
Nijmegen, Netherlands
Investigational Site Number : 5280001Recruiting
Tilburg, Netherlands
Investigational Site Number : 5280003Recruiting
Utrecht, Netherlands
Investigational Site Number : 6160005Recruiting
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160006Recruiting
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6160004Recruiting
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160001Recruiting
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002Recruiting
Sopot, Pomeranian Voivodeship, Poland
Investigational Site Number : 6420004Recruiting
Bucharest, Romania
Investigational Site Number : 6420003Recruiting
Constanța, Romania
Investigational Site Number : 6420001Recruiting
Timișoara, Romania
Investigational Site Number : 4100002Recruiting
Haeundae-Gu, Busan, South Korea
Investigational Site Number : 4100001Recruiting
Daegu, Daegu, South Korea
Investigational Site Number : 4100003Recruiting
Daejeon, Daejeon, South Korea
Investigational Site Number : 7240002Recruiting
Seville, Sevilla, Spain
Investigational Site Number : 7240001Recruiting
Madrid, Spain
Investigational Site Number : 7920003Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920001Recruiting
Mersin, Turkey (Türkiye)
Investigational Site Number : 7920002Recruiting
Zonguldak, Turkey (Türkiye)