A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (SPECIFI-CD)

May 19, 2026 updated by: Sanofi

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.

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.

Study Overview

Status

Recruiting

Conditions

Crohn's Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Trial Transparency email recommended (Toll free for US & Canada)
Phone Number: option 6 800-633-1610
Email: Contact-US@sanofi.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1061
    - Recruiting
    - Investigational Site Number : 0320003
  - Buenos Aires, Argentina, 1125
    - Recruiting
    - Investigational Site Number : 0320001
  - Buenos Aires, Argentina, 1119
    - Recruiting
    - Investigational Site Number : 0320005
  - Buenos Aires, Argentina, 1221
    - Recruiting
    - Investigational Site Number : 0320004
  - Buenos Aires, Argentina, 1280
    - Recruiting
    - Investigational Site Number : 0320006
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Recruiting
    - Investigational Site Number : 0320002
Australia
- New South Wales
  - Sydney, New South Wales, Australia, 2139
    - Recruiting
    - Investigational Site Number : 0360002
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Investigational Site Number : 0360001
- Victoria
  - Parkville, Victoria, Australia, 3050
    - Recruiting
    - Investigational Site Number : 0360003
Brazil
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 41820-020
    - Recruiting
    - Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
    - Recruiting
    - Hospital Ernesto Dornelles- Site Number : 0760002
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
    - Recruiting
    - Hospital Moinhos de Vento- Site Number : 0760006
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035903
    - Recruiting
    - Hospital de Clinicas de Porto Alegre- Site Number : 0760007
- São Paulo
  - Santo André, São Paulo, Brazil, 09080-110
    - Recruiting
    - Pesquisare Saude- Site Number : 0760004
Bulgaria
- - Gorna Oryahovitsa, Bulgaria, 5100
    - Recruiting
    - Investigational Site Number : 1000001
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Investigational Site Number : 1000005
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Investigational Site Number : 1000004
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Recruiting
    - Investigational Site Number : 1240001
- Quebec
  - Montreal, Quebec, Canada, H3H 1E8
    - Recruiting
    - Investigational Site Number : 1240003
  - Québec, Quebec, Canada, G1N 4V3
    - Recruiting
    - Investigational Site Number : 1240005
Chile
- Biobio
  - Concepción, Biobio, Chile, 4070038
    - Recruiting
    - Investigational Site Number : 1520006
  - Talcahuano, Biobio, Chile, 2687000
    - Recruiting
    - Investigational Site Number : 1520004
- La Araucanía
  - Temuco, La Araucanía, Chile, 4781156
    - Recruiting
    - Investigational Site Number : 1520007
- Reg Metropolitana de Santiago
  - Santiago, Reg Metropolitana de Santiago, Chile, 8331143
    - Recruiting
    - Investigational Site Number : 1520001
  - Santiago, Reg Metropolitana de Santiago, Chile, 8380456
    - Recruiting
    - Investigational Site Number : 1520003
- Valparaiso
  - Viña del Mar, Valparaiso, Chile, 2540364
    - Recruiting
    - Investigational Site Number : 1520002
China
- - Changzhou, China, 213003
    - Recruiting
    - Investigational Site Number : 1560008
  - Chongqing, China, 400013
    - Recruiting
    - Investigational Site Number : 1560009
  - Fuzhou, China, 350005
    - Recruiting
    - Investigational Site Number : 1560012
  - Guangzhou, China, 510080
    - Recruiting
    - Investigational Site Number : 1560001
  - Guangzhou, China, 510655
    - Recruiting
    - Investigational Site Number : 1560002
  - Hangzhou, China, 310009
    - Recruiting
    - Investigational Site Number : 1560004
  - Hangzhou, China, 310016
    - Recruiting
    - Investigational Site Number : 1560003
  - Hefei, China, 230022
    - Recruiting
    - Investigational Site Number : 1560007
  - Nanchang, China, 330006
    - Recruiting
    - Investigational Site Number : 1560011
  - Shanghai, China, 200025
    - Recruiting
    - Investigational Site Number : 1560006
  - Shanghai, China, 200127
    - Recruiting
    - Investigational Site Number : 1560005
  - Suzhou, China, 215004
    - Recruiting
    - Investigational Site Number : 1560010
Croatia
- - Osijek, Croatia, 31000
    - Recruiting
    - Investigational Site Number : 1910004
  - Zagreb, Croatia, 10000
    - Recruiting
    - Investigational Site Number : 1910003
Czechia
- - Brno, Czechia, 602 00
    - Recruiting
    - Investigational Site Number : 2030003
  - Brno, Czechia, 636 00
    - Recruiting
    - Investigational Site Number : 2030002
  - Hradec Králové, Czechia, 500 12
    - Recruiting
    - Investigational Site Number : 2030004
France
- - Montpellier, France, 34295
    - Recruiting
    - Investigational Site Number : 2500005
  - Nice, France, 06202
    - Recruiting
    - Investigational Site Number : 2500002
  - Saint-Priest-en-Jarez, France, 42270
    - Recruiting
    - Investigational Site Number : 2500004
  - Toulouse, France, 31059
    - Recruiting
    - Investigational Site Number : 2500003
  - Vandœuvre-lès-Nancy, France, 54511
    - Recruiting
    - Investigational Site Number : 2500001
Georgia
- - Kutaisi, Georgia, 4600
    - Recruiting
    - Investigational Site Number : 2680006
  - Tbilisi, Georgia, 0160
    - Recruiting
    - Investigational Site Number : 2680002
  - Tbilisi, Georgia, 0102
    - Recruiting
    - Investigational Site Number : 2680007
  - Tbilisi, Georgia, 0144
    - Recruiting
    - Investigational Site Number : 2680001
  - Tbilisi, Georgia, 0159
    - Recruiting
    - Investigational Site Number : 2680005
  - Tbilisi, Georgia, 0180
    - Recruiting
    - Investigational Site Number : 2680004
  - Tbilisi, Georgia, 0172
    - Recruiting
    - Investigational Site Number : 2680003
Germany
- - Berlin, Germany, 12203
    - Recruiting
    - Investigational Site Number : 2760002
  - Berlin, Germany, 10318
    - Recruiting
    - Investigational Site Number : 2760004
  - Fulda, Germany, 36043
    - Recruiting
    - Investigational Site Number : 2760001
  - Halle, Germany, 06108
    - Recruiting
    - Investigational Site Number : 2760005
  - Ludwigshafen, Germany, 67067
    - Recruiting
    - Investigational Site Number : 2760006
Hungary
- - Budapest, Hungary, 1085
    - Recruiting
    - Investigational Site Number : 3480008
  - Békéscsaba, Hungary, 5600
    - Recruiting
    - Investigational Site Number : 3480003
  - Eger, Hungary, 3300
    - Recruiting
    - Investigational Site Number : 3480010
  - Gyöngyös, Hungary, 3200
    - Recruiting
    - Investigational Site Number : 3480009
  - Gyöngyös, Hungary, 3200
    - Recruiting
    - Investigational Site Number : 3480001
  - Szeged, Hungary, 6720
    - Recruiting
    - Investigational Site Number : 3480005
  - Szekszárd, Hungary, 7100
    - Recruiting
    - Investigational Site Number : 3480006
  - Tatabánya, Hungary, 2800
    - Recruiting
    - Investigational Site Number : 3480004
India
- - Hyderabad, India, 500048
    - Recruiting
    - Investigational Site Number : 3560003
  - Hyderabad, India, 500032
    - Recruiting
    - Investigational Site Number : 3560007
  - Jaipur, India, 302001
    - Recruiting
    - Investigational Site Number : 3560009
  - Jaipur, India, 302007
    - Recruiting
    - Investigational Site Number : 3560001
  - Kolkata, India, 700020
    - Recruiting
    - Investigational Site Number : 3560005
  - Pune, India, 412201
    - Recruiting
    - Investigational Site Number : 3560006
  - Secunderabad, India, 500003
    - Recruiting
    - Investigational Site Number : 3560002
  - Surat, India, 395002
    - Recruiting
    - Investigational Site Number : 3560013
  - Surat, India, 395010
    - Recruiting
    - Investigational Site Number : 3560010
Italy
- - Pisa, Italy, 56124
    - Recruiting
    - Investigational Site Number : 3800005
- Milano
  - Milan, Milano, Italy, 20132
    - Recruiting
    - Investigational Site Number : 3800002
  - Milan, Milano, Italy, 20097
    - Recruiting
    - Investigational Site Number : 3800009
  - Rozzano, Milano, Italy, 20089
    - Recruiting
    - Investigational Site Number : 3800004
- Padova
  - Padua, Padova, Italy, 35128
    - Recruiting
    - Investigational Site Number : 3800001
- Roma
  - Rome, Roma, Italy, 00168
    - Recruiting
    - Investigational Site Number : 3800006
  - Rome, Roma, Italy, 00128
    - Recruiting
    - Investigational Site Number : 3800008
Japan
- - Hiroshima, Japan, 734-0004
    - Recruiting
    - Investigational Site Number : 3920013
  - Tokyo, Japan, 169-0073
    - Recruiting
    - Investigational Site Number : 3920011
  - Wakayama, Japan, 640-8558
    - Recruiting
    - Investigational Site Number : 3920012
  - Ōita, Japan, 870-0033
    - Recruiting
    - Investigational Site Number : 3920018
- Chiba
  - Kashiwa, Chiba, Japan, 277-0871
    - Recruiting
    - Investigational Site Number : 3920004
  - Sakura, Chiba, Japan, 285-0841
    - Recruiting
    - Investigational Site Number : 3920001
- Fukuoka
  - Kitakyushu, Fukuoka, Japan, 802-0077
    - Recruiting
    - Investigational Site Number : 3920005
- Hokkaido
  - Sapporo, Hokkaido, Japan, 064-0919
    - Recruiting
    - Investigational Site Number : 3920010
  - Sapporo, Hokkaido, Japan, 004-0041
    - Recruiting
    - Investigational Site Number : 3920006
  - Sapporo, Hokkaido, Japan, 065-0033
    - Recruiting
    - Investigational Site Number : 3920007
- Iwate
  - Yahaba, Iwate, Japan, 028-3695
    - Recruiting
    - Investigational Site Number : 3920008
- Kagawa-ken
  - Takamatsu, Kagawa-ken, Japan, 760-0017
    - Recruiting
    - Investigational Site Number : 3920019
- Niigata
  - Nagaoka, Niigata, Japan, 940-2108
    - Recruiting
    - Investigational Site Number : 3920020
- Tokyo
  - Bunkyo, Tokyo, Japan, 113-8510
    - Recruiting
    - Investigational Site Number : 3920003
Mauritius
- - Vacoas, Mauritius, 72218
    - Recruiting
    - Investigational Site Number : 4800001
Netherlands
- - Breda, Netherlands, 4818 CK
    - Recruiting
    - Investigational Site Number : 5280004
  - Nijmegen, Netherlands, 6525 GA
    - Recruiting
    - Investigational Site Number : 5280002
  - Tilburg, Netherlands, 5022 GC
    - Recruiting
    - Investigational Site Number : 5280001
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - Investigational Site Number : 5280003
Poland
- Kuyavian-Pomeranian Voivodeship
  - Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
    - Recruiting
    - Investigational Site Number : 6160005
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-582
    - Recruiting
    - Investigational Site Number : 6160006
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-507
    - Recruiting
    - Investigational Site Number : 6160001
  - Warsaw, Masovian Voivodeship, Poland, 00-332
    - Recruiting
    - Investigational Site Number : 6160004
- Pomeranian Voivodeship
  - Sopot, Pomeranian Voivodeship, Poland, 81-756
    - Recruiting
    - Investigational Site Number : 6160002
Romania
- - Bucharest, Romania, 011461
    - Recruiting
    - Investigational Site Number : 6420004
  - Constanța, Romania, 900673
    - Recruiting
    - Investigational Site Number : 6420003
  - Timișoara, Romania, 300002
    - Recruiting
    - Investigational Site Number : 6420001
South Korea
- Busan
  - Haeundae-Gu, Busan, South Korea, 48108
    - Recruiting
    - Investigational Site Number : 4100002
- Daegu
  - Daegu, Daegu, South Korea, 41944
    - Recruiting
    - Investigational Site Number : 4100001
- Daejeon
  - Daejeon, Daejeon, South Korea, 34943
    - Recruiting
    - Investigational Site Number : 4100003
Spain
- - Madrid, Spain, 28046
    - Recruiting
    - Investigational Site Number : 7240001
- Sevilla
  - Seville, Sevilla, Spain, 41009
    - Recruiting
    - Investigational Site Number : 7240002
Turkey (Türkiye)
- - Istanbul, Turkey (Türkiye), 34899
    - Recruiting
    - Investigational Site Number : 7920003
  - Mersin, Turkey (Türkiye), 33070
    - Recruiting
    - Investigational Site Number : 7920001
  - Sanliurfa, Turkey (Türkiye), 63290
    - Recruiting
    - Investigational Site Number : 7920006
United States
- Arizona
  - Sun City, Arizona, United States, 85351
    - Recruiting
    - GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
- Connecticut
  - Bristol, Connecticut, United States, 06010
    - Recruiting
    - Bristol Hospital- Site Number : 8400007
- Florida
  - Clermont, Florida, United States, 34711
    - Recruiting
    - Novum Research- Site Number : 8400021
  - Homestead, Florida, United States, 33033
    - Recruiting
    - Homestead Associates in Research- Site Number : 8400012
  - Kissimmee, Florida, United States, 34741
    - Recruiting
    - Clinical Research of Osceola- Site Number : 8400013
  - Miami Lakes, Florida, United States, 33016
    - Recruiting
    - Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
  - Tampa, Florida, United States, 33609
    - Recruiting
    - GCP Clinical Research- Site Number : 8400004
- Illinois
  - Glenview, Illinois, United States, 60026
    - Recruiting
    - GI Alliance - Glenview- Site Number : 8400015
  - Gurnee, Illinois, United States, 60031
    - Recruiting
    - Illinois Gastroenterology Group- Site Number : 8400011
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Health System - Ann Arbor- Site Number : 8400017
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Recruiting
    - Gi Alliance - Flowood- Site Number : 8400019
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Recruiting
    - Vector Clinical Trials- Site Number : 8400001
- New York
  - Queens Village, New York, United States, 11428
    - Recruiting
    - Queens Village Primary Medical Center- Site Number : 8400005
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
- Pennsylvania
  - Uniontown, Pennsylvania, United States, 15401
    - Recruiting
    - Frontier Clinical Research - Uniontown- Site Number : 8400009
- South Carolina
  - Charleston, South Carolina, United States, 29401
    - Recruiting
    - Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016
- Texas
  - Katy, Texas, United States, 77494
    - Recruiting
    - Gastro Health & Nutrition- Site Number : 8400003
  - Southlake, Texas, United States, 76092
    - Recruiting
    - Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
- Washington
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Washington Gastroenterology - Tacoma- Site Number : 8400008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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
Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
Participants who received IV corticosteroids within 14 days prior to screening or during screening period
Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR441566 dose 1 Participants will receive SAR441566 dose 1.	Drug: SAR441566 Pharmaceutical form: Tablet Route of administration: Oral
Experimental: SAR441566 dose 2 Participants will receive SAR441566 dose 2.	Drug: SAR441566 Pharmaceutical form: Tablet Route of administration: Oral
Experimental: SAR441566 dose 3 Participants will receive SAR441566 dose 3.	Drug: SAR441566 Pharmaceutical form: Tablet Route of administration: Oral
Placebo Comparator: Placebo Participants will receive SAR441566 matching placebo.	Drug: SAR441566 matching Placebo Pharmaceutical form: Tablet Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving endoscopic response Time Frame: Week 12	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI) Time Frame: Week 12	CDAI clinical remission is defined as CDAI score <150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.	Week 12
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission Time Frame: Week 12	PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score ≤1, and the unweighted CDAI component of daily average stool frequency (SF) score ≤3 (ie, AP ≤1 and SF ≤3 and no worsening from baseline).	Week 12
Proportion of participants achieving both clinical remission and endoscopic response Time Frame: Week 12	Clinical remission and endoscopic response based on CDAI <150 and ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD)	Week 12
Proportion of participants achieving endoscopic remission based on centrally read SES-CD Time Frame: From Baseline to Week 12	Endoscopic remission is defined as a centrally read SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease from baseline ≥2 points with no SES-CD sub score >1 point	From Baseline to Week 12
Proportion of participants achieving CDAI clinical response Time Frame: From Baseline to Week 12	CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points.	From Baseline to Week 12
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission Time Frame: Week 12	IBDQ remission is defined as IBDQ total score ≥170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life.	Week 12
Proportion of participants achieving IBDQ response Time Frame: From baseline to Week 12	IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline	From baseline to Week 12
Change from baseline in the IBDQ scores Time Frame: From Baseline to week 12	The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement.	From Baseline to week 12
Number of participants experiencing any TEAEs Time Frame: Up to week 52	Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period	Up to week 52
Plasma pre-dose concentrations of SAR441566 at selected visits Time Frame: Up to week 52		Up to week 52
Plasma post-dose concentrations of SAR441566 at selected visits Time Frame: Up to week 52		Up to week 52
Number of participants experiencing any TEAEs Time Frame: From week 12 to week 52	Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period	From week 12 to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

DRI18212 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

May 23, 2029

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

DRI18212
2024-512633-32-00 (Registry Identifier: CTIS)
U1111-1301-3830 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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Clinical Trials on Crohn's Disease

ProgenaBiome

Withdrawn

A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease

Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Crohn's | Crohn Disease of Ileum | Crohn Ileitis | Crohn's Disease Relapse | Crohns Disease Aggravated | Crohn Disease in Remission | Crohn's Disease of Pylorus

United States
Sixth Affiliated Hospital, Sun Yat-sen University

Not yet recruiting

Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, Parallel-Controlled Study

Crohn's Disease Aggravated | Crohn's Disease in Remission
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American...

Recruiting

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

Inflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis

United States
Tanabe Pharma Corporation

Completed

Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

Pediatric Crohn's Disease

Japan
Massachusetts General Hospital

Recruiting

Family Members At INcreased-risk for Developing Inflammatory Bowel Disease (FIND-IBD)

Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Inflammatory Bowel Disease (IBD) | Crohn's Colitis | Indeterminate Colitis | Ulcerative Colitis (UC) | Ulcerative Proctitis | Ulcerative Proctosigmoiditis | Crohn's Disease Colon | IBD-unclassified (IBD-U)

United States
Richard Burt, MD

Terminated

Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease

CROHN'S DISEASE

United States
Kate Farms Inc
University of Minnesota

Completed

Partial-enteral Nutrition Protocol for Crohn's Disease

Crohn's Disease(CD)

United States
Agomab Spain S.L.U.

Active, not recruiting

STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

Fibrostenotic Crohn's Disease

United States, Spain, Denmark, Austria, Poland, Italy, Canada, Germany
AbbVie

Completed

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

Crohn's Disease (CD)

United States, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Romania, Spain, United Kingdom, Poland, Slovakia, Belgium
Sheba Medical Center

Completed

The CURE - CD Trial

CD - Crohn's Disease

Israel

Clinical Trials on SAR441566

Sanofi

Recruiting

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis (SPECIFI-UC)

Colitis Ulcerative

Belgium, Italy, Germany, Georgia, South Africa, United States, Austria, Hungary, Greece, Argentina, Japan, China, Canada, Australia, Bulgaria, Czechia, France, Turkey (Türkiye), Chile, India, Poland, Brazil
Sanofi

Completed

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.

Rheumatoid Arthritis

United States
Sanofi

Completed

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (SPECIFI-PSO)

Psoriasis

Germany, Hungary, Spain, Japan, Mauritius, United States, Canada, China, Czechia, Georgia, Poland, Portugal, United Kingdom, Chile, Argentina, Bulgaria, Turkey (Türkiye)
Sanofi

Completed

A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis

Psoriasis

Germany
Sanofi

Enrolling by invitation

A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)

Crohn's Disease | Colitis Ulcerative

Bulgaria, Chile
Sanofi

Completed

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (SPECIFI-RA)

Rheumatoid Arthritis

Spain, China, Greece, Germany, Chile, United States, Argentina, Brazil, Canada, Czechia, Georgia, India, Japan, Mauritius, Mexico, Poland, Puerto Rico, Slovakia, South Africa
Sanofi

Active, not recruiting

A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.

Healthy Volunteers | Cardiac Repolarization

United States
Sanofi

Completed

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566

Rheumatoid Arthritis

United States

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (SPECIFI-CD)

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.

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

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Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

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Secondary Outcome Measures

Outcome Measure

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Last Update Submitted That Met QC Criteria

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Crohn's Disease

Clinical Trials on SAR441566

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