A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

NCT06637631 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI182122024-512633-32-00U1111-1301-3830
• Study Type: interventional
• Target: 260
• Locations: 24 countries
• Sites: 138

Brief Summary

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving endoscopic response

  Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

  Week 12

Secondary Outcomes (12)

• Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)

  Week 12

• Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission

  Week 12

• Proportion of participants achieving both clinical remission and endoscopic response

  Week 12

• Proportion of participants achieving endoscopic remission based on centrally read SES-CD

  From Baseline to Week 12

• Proportion of participants achieving CDAI clinical response

  From Baseline to Week 12

Study Arms (4)

SAR441566 dose 1

EXPERIMENTAL

Participants will receive SAR441566 dose 1.

Drug: SAR441566

SAR441566 dose 2

EXPERIMENTAL

Participants will receive SAR441566 dose 2.

Drug: SAR441566

SAR441566 dose 3

EXPERIMENTAL

Participants will receive SAR441566 dose 3.

Drug: SAR441566

Placebo

PLACEBO COMPARATOR

Participants will receive SAR441566 matching placebo.

Drug: SAR441566 matching Placebo

Interventions

SAR441566 DRUG

Pharmaceutical form: Tablet Route of administration: Oral

SAR441566 dose 1; SAR441566 dose 2; SAR441566 dose 3

SAR441566 matching Placebo DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Male or female participants aged 18 to 75 years at the time of signing the ICF
• Confirmed diagnosis of CD for at least 3 months prior to Baseline
• 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
• 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
• On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Participants with active UC, indeterminate colitis or short bowel syndrome
• Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
• 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
• Participants with stool sample positive for infectious pathogens
• Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
• 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
• Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
• Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
• Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
• History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
• Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
• Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
• Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
• Participants who received fecal microbial transplantation within 30 days prior to screening

Sponsors & Collaborators

• Sanofi: lead

Study Sites (138)

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020

Sun City, Arizona, 85351, United States

RECRUITING

Bristol Hospital- Site Number : 8400007

Bristol, Connecticut, 06010, United States

RECRUITING

Novum Research- Site Number : 8400021

Clermont, Florida, 34711, United States

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Homestead Associates in Research- Site Number : 8400012

Homestead, Florida, 33033, United States

RECRUITING

Clinical Research of Osceola- Site Number : 8400013

Kissimmee, Florida, 34741, United States

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Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010

Miami Lakes, Florida, 33016, United States

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GCP Clinical Research- Site Number : 8400004

Tampa, Florida, 33609, United States

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GI Alliance - Glenview- Site Number : 8400015

Glenview, Illinois, 60026, United States

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Illinois Gastroenterology Group- Site Number : 8400011

Gurnee, Illinois, 60031, United States

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University of Michigan Health System - Ann Arbor- Site Number : 8400017

Ann Arbor, Michigan, 48109, United States

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GI Alliance - Flowood- Site Number : 8400019

Flowood, Mississippi, 39232, United States

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Vector Clinical Trials- Site Number : 8400001

Las Vegas, Nevada, 89128, United States

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Queens Village Primary Medical Center- Site Number : 8400005

Queens Village, New York, 11428, United States

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Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014

Greenville, North Carolina, 27834, United States

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Frontier Clinical Research - Uniontown- Site Number : 8400009

Uniontown, Pennsylvania, 15401, United States

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Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016

Charleston, South Carolina, 29401, United States

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Gastro Health & Nutrition- Site Number : 8400003

Katy, Texas, 77494, United States

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Texas Digestive Disease Consultants - Southlake- Site Number : 8400002

Southlake, Texas, 76092, United States

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Washington Gastroenterology - Tacoma- Site Number : 8400008

Tacoma, Washington, 98405, United States

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Investigational Site Number : 0320002

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Investigational Site Number : 0320003

Buenos Aires, 1061, Argentina

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Investigational Site Number : 0320005

Buenos Aires, 1119, Argentina

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Investigational Site Number : 0320001

Buenos Aires, 1125, Argentina

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Investigational Site Number : 0320004

Buenos Aires, 1221, Argentina

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Investigational Site Number : 0320006

Buenos Aires, 1280, Argentina

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Investigational Site Number : 0360002

Sydney, New South Wales, 2139, Australia

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Investigational Site Number : 0360001

South Brisbane, Queensland, 4101, Australia

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Investigational Site Number : 0360003

Parkville, Victoria, 3050, Australia

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Centro de Pesquisas da Clínica IBIS- Site Number : 0760001

Salvador, Estado de Bahia, 41820-020, Brazil

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Hospital Moinhos de Vento- Site Number : 0760006

Porto Alegre, Rio Grande do Sul, 90035-902, Brazil

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Hospital de Clinicas de Porto Alegre- Site Number : 0760007

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

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Hospital Ernesto Dornelles- Site Number : 0760002

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

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Pesquisare Saude- Site Number : 0760004

Santo André, São Paulo, 09080-110, Brazil

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Investigational Site Number : 1000001

Gorna Oryahovitsa, 5100, Bulgaria

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Investigational Site Number : 1000004

Sofia, 1431, Bulgaria

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Investigational Site Number : 1000005

Sofia, 1680, Bulgaria

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Investigational Site Number : 1240001

Calgary, Alberta, T2N 4Z6, Canada

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Investigational Site Number : 1240003

Montreal, Quebec, H3H 1E8, Canada

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Investigational Site Number : 1240005

Québec, Quebec, G1N 4V3, Canada

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Investigational Site Number : 1520006

Concepción, Biobio, 4070038, Chile

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Investigational Site Number : 1520004

Talcahuano, Biobio, 2687000, Chile

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Investigational Site Number : 1520007

Temuco, La Araucanía, 4781156, Chile

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Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8331143, Chile

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Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 8380456, Chile

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Investigational Site Number : 1520002

Viña del Mar, Valparaiso, 2540364, Chile

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Investigational Site Number : 1560008

Changzhou, 213003, China

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Investigational Site Number : 1560009

Chongqing, 400013, China

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Investigational Site Number : 1560012

Fuzhou, 350005, China

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Investigational Site Number : 1560001

Guangzhou, 510080, China

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Investigational Site Number : 1560002

Guangzhou, 510655, China

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Investigational Site Number : 1560004

Hangzhou, 310009, China

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Investigational Site Number : 1560003

Hangzhou, 310016, China

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Investigational Site Number : 1560007

Hefei, 230022, China

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Investigational Site Number : 1560011

Nanchang, 330006, China

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Investigational Site Number : 1560006

Shanghai, 200025, China

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Investigational Site Number : 1560005

Shanghai, 200127, China

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Investigational Site Number : 1560010

Suzhou, 215004, China

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Investigational Site Number : 1910004

Osijek, 31000, Croatia

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Investigational Site Number : 1910003

Zagreb, 10000, Croatia

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Investigational Site Number : 2030003

Brno, 602 00, Czechia

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Investigational Site Number : 2030002

Brno, 636 00, Czechia

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Investigational Site Number : 2030004

Hradec Králové, 500 12, Czechia

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Investigational Site Number : 2500005

Montpellier, 34295, France

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Investigational Site Number : 2500002

Nice, 06202, France

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Investigational Site Number : 2500004

Saint-Priest-en-Jarez, 42270, France

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Investigational Site Number : 2500003

Toulouse, 31059, France

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Investigational Site Number : 2500001

Vandœuvre-lès-Nancy, 54511, France

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Investigational Site Number : 2680006

Kutaisi, 4600, Georgia

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Investigational Site Number : 2680007

Tbilisi, 0102, Georgia

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Investigational Site Number : 2680001

Tbilisi, 0144, Georgia

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Investigational Site Number : 2680005

Tbilisi, 0159, Georgia

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Investigational Site Number : 2680002

Tbilisi, 0160, Georgia

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Investigational Site Number : 2680003

Tbilisi, 0172, Georgia

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Investigational Site Number : 2680004

Tbilisi, 0180, Georgia

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Investigational Site Number : 2760004

Berlin, 10318, Germany

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Investigational Site Number : 2760002

Berlin, 12203, Germany

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Investigational Site Number : 2760001

Fulda, 36043, Germany

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Investigational Site Number : 2760005

Halle, 06108, Germany

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Investigational Site Number : 2760006

Ludwigshafen, 67067, Germany

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Investigational Site Number : 3480003

Békéscsaba, 5600, Hungary

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Investigational Site Number : 3480008

Budapest, 1085, Hungary

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Investigational Site Number : 3480001

Gyöngyös, 3200, Hungary

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Investigational Site Number : 3480009

Gyöngyös, 3200, Hungary

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Investigational Site Number : 3480005

Szeged, 6720, Hungary

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Investigational Site Number : 3480006

Szekszárd, 7100, Hungary

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Investigational Site Number : 3480004

Tatabánya, 2800, Hungary

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Investigational Site Number : 3560007

Hyderabad, 500032, India

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Investigational Site Number : 3560003

Hyderabad, 500048, India

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Investigational Site Number : 3560009

Jaipur, 302001, India

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Investigational Site Number : 3560001

Jaipur, 302007, India

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Investigational Site Number : 3560005

Kolkata, 700020, India

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Investigational Site Number : 3560006

Pune, 412201, India

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Investigational Site Number : 3560002

Secunderabad, 500003, India

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Investigational Site Number : 3560013

Surat, 395002, India

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Investigational Site Number : 3560010

Surat, 395010, India

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Investigational Site Number : 3800009

Milan, Milano, 20097, Italy

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Investigational Site Number : 3800002

Milan, Milano, 20132, Italy

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Investigational Site Number : 3800004

Rozzano, Milano, 20089, Italy

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Investigational Site Number : 3800001

Padua, Padova, 35128, Italy

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Investigational Site Number : 3800008

Rome, Roma, 00128, Italy

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Investigational Site Number : 3800006

Rome, Roma, 00168, Italy

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Investigational Site Number : 3800005

Pisa, 56124, Italy

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Investigational Site Number : 3920004

Kashiwa, Chiba, 277-0871, Japan

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Investigational Site Number : 3920001

Sakura, Chiba, 285-0841, Japan

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Investigational Site Number : 3920005

Kitakyushu, Fukuoka, 802-0077, Japan

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Investigational Site Number : 3920006

Sapporo, Hokkaido, 004-0041, Japan

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Investigational Site Number : 3920010

Sapporo, Hokkaido, 064-0919, Japan

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Investigational Site Number : 3920007

Sapporo, Hokkaido, 065-0033, Japan

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Investigational Site Number : 3920008

Yahaba, Iwate, 028-3695, Japan

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Investigational Site Number : 3920019

Takamatsu, Kagawa-ken, 760-0017, Japan

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Investigational Site Number : 3920020

Nagaoka, Niigata, 940-2108, Japan

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Investigational Site Number : 3920003

Bunkyo, Tokyo, 113-8510, Japan

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Investigational Site Number : 3920013

Hiroshima, 734-0004, Japan

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Investigational Site Number : 3920018

Ōita, 870-0033, Japan

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Investigational Site Number : 3920011

Tokyo, 169-0073, Japan

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Investigational Site Number : 3920012

Wakayama, 640-8558, Japan

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Investigational Site Number : 4800001

Vacoas, 72218, Mauritius

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Investigational Site Number : 5280004

Breda, 4818 CK, Netherlands

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Investigational Site Number : 5280002

Nijmegen, 6525 GA, Netherlands

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Investigational Site Number : 5280001

Tilburg, 5022 GC, Netherlands

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Investigational Site Number : 5280003

Utrecht, 3584 CX, Netherlands

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Investigational Site Number : 6160005

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

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Investigational Site Number : 6160006

Lublin, Lublin Voivodeship, 20-582, Poland

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Investigational Site Number : 6160004

Warsaw, Masovian Voivodeship, 00-332, Poland

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Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 02-507, Poland

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Investigational Site Number : 6160002

Sopot, Pomeranian Voivodeship, 81-756, Poland

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Investigational Site Number : 6420004

Bucharest, 011461, Romania

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Investigational Site Number : 6420003

Constanța, 900673, Romania

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Investigational Site Number : 6420001

Timișoara, 300002, Romania

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Investigational Site Number : 4100002

Haeundae-Gu, Busan, 48108, South Korea

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Investigational Site Number : 4100001

Daegu, Daegu, 41944, South Korea

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Investigational Site Number : 4100003

Daejeon, Daejeon, 34943, South Korea

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Investigational Site Number : 7240002

Seville, Sevilla, 41009, Spain

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Investigational Site Number : 7240001

Madrid, 28046, Spain

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Investigational Site Number : 7920003

Istanbul, 34899, Turkey (Türkiye)

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Investigational Site Number : 7920001

Mersin, 33070, Turkey (Türkiye)

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Investigational Site Number : 7920006

Sanliurfa, 63290, Turkey (Türkiye)

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Investigational Site Number : 7920002

Zonguldak, 67000, Turkey (Türkiye)

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Related Links

• DRI18212 Plain Language Results Summary

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): July 21, 2027
• Study Completion (Estimated): May 23, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (5); DE (5); MA (1); HU (7); CL (6); AU (3); IN (9); CR (2); GE (7); IT (7); TU (4); US (19); CN (12); AR (6); RO (3); KR (3); FR (5); JP (14); CA (3); CZ (3); BU (3); PL (5); ES (2); NL (4)