An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC183262025-521036-11U1111-1314-5319
• Study Type: interventional
• Target: 980
• Locations: 20 countries
• Sites: 195

Brief Summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with:

• Up to 5-week Screening Period.
• 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction).
• 12-week Sub-Study 3 (Extended Induction for non-responders).
• 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (4)

• Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12

  Clinical Remission by CDAI: CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.

  Week 12

• Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn&#x0027;s Disease [SES-CD]) at Week 12

  Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.

  Week 12

• Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12

  Clinical Remission per PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.

  Week 12

• Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12

  Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.

  Week 12

Secondary Outcomes (17)

• Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12

  Week 12

• Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12

  Week 12

• Sub-study 2: Proportion of participants achieving endoscopic SES-CD remission at Week 12

  Week 12

• Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12

  Week 12

• Sub-study 2: EU/EMA: Proportion of participants achievingclinical remission per CDAI at Week 12

  Week 12

Study Arms (3)

Duvakitug Dose 1

EXPERIMENTAL

Subcutaneous (SC) Injection as per protocol

Drug: Duvakitug

Duvakitug Dose 2

EXPERIMENTAL

SC injection as per protocol

Drug: Duvakitug

Placebo

PLACEBO COMPARATOR

SC injection as per protocol

Drug: Placebo

Interventions

Duvakitug DRUG

Pharmaceutical form:Injection solution Route of administration:SC injection

Also known as: SAR447189

Duvakitug Dose 1; Duvakitug Dose 2

Placebo DRUG

Pharmaceutical form:Injection solution Route of administration:SC injection

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development
• Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline
• Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

You may not qualify if:

• Participants with Ulcerative Colitis (UC) or indeterminate colitis
• Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
• Prior or current high-grade gastrointestinal (GI) dysplasia
• Participants on treatment with but not on stable doses of conventional therapy prior to baseline
• Participants receiving prohibited medications or therapies
• Participants with previous exposure to anti-TL1A investigational therapy
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead
• Teva Branded Pharmaceutical Products R&D LLC: collaborator

Study Sites (196)

Onyx Clinical Research - Site Number: 8400021

Peoria, Arizona, 85381, United States

RECRUITING

One of a Kind Clinical Research Center LLC-Site Number: 8400061

Scottsdale, Arizona, 85258, United States

RECRUITING

Del Sol Research Management, LLC-Site Number: 8400012

Tucson, Arizona, 85715, United States

RECRUITING

Preferred Research Partners: 8400018

Little Rock, Arkansas, 72211, United States

RECRUITING

Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008

Canoga Park, California, 91304, United States

RECRUITING

Southern California GI & Liver Centers-Site Number: 8400062

Coronado, California, 92118-1408, United States

RECRUITING

GMC Clinical Research, LLC-Site Number: 8400113

Folsom, California, 95630, United States

RECRUITING

TLC Clinical Research Inc.: 8400030

Los Angeles, California, 90048, United States

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United Medical Doctors CA-Site Number: 8400044

Murrieta, California, 92563, United States

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Prospective Research Innovations Inc.: 8400017

Rancho Cucamonga, California, 91730, United States

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Medical Associates Research Group-Site Number: 8400063

San Diego, California, 92123, United States

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Valiance Clinical Research - Tarzana: 8400023

Tarzana, California, 91356, United States

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Clinical Trials Management Services-Site Number: 8400047

Thousand Oaks, California, 91360, United States

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Amicis Research Center-Valencia-Site Number: 8400064

Valencia, California, 91355, United States

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Om Research, LLC - Victorville - Site Number: 8400022

Victorville, California, 92395, United States

RECRUITING

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

Colorado Springs, Colorado, 80907, United States

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Gastroenterology of the Rockies - Denver-Site Number: 8400122

Denver, Colorado, 80218, United States

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Novum Research, LLC-Site Number: 8400003

Clermont, Florida, 34711, United States

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Precision Clinical Research: 8400059

Coral Springs, Florida, 33065, United States

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Sarkis Clinical Trials-Ocala-Site Number: 8400048

Gainesville, Florida, 32607, United States

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Clinical Research of Osceola-Site Number: 8400013

Kissimmee, Florida, 34741, United States

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Columbus Clinical Services LLc-Site Number: 8400038

Miami, Florida, 33125, United States

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Regis Clinical Research, LLC-Site Number: 8400041

Miami, Florida, 33126, United States

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Bio Research Partner-Site Number: 8400053

Miami, Florida, 33155, United States

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Medical Professional Clinical Research Center-Site Number: 8400119

Miami, Florida, 33165, United States

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Correa Research Center-Site Number: 8400010

Miami, Florida, 33186, United States

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Orlando Health, Inc.-Site Number: 8400084

Orlando, Florida, 32806, United States

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Tropical Clinical Trials-Site Number: 8400082

Palmetto Bay, Florida, 33176, United States

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NMC Research LLC - Site Number: 8400033

Tampa, Florida, 33607, United States

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Atlanta Gastroenterology Associates-Site Number: 8400109

Atlanta, Georgia, 30342, United States

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M3 Wake Research - Atlanta: 8400028

Sandy Springs, Georgia, 30328, United States

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EBGS Clinical Research Center, LLC-Site Number 8400037

Snellville, Georgia, 30078, United States

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Grand Teton Research Group, PLLC-Site Number: 8400127

Idaho Falls, Idaho, 83404, United States

RECRUITING

Midwest Digestive Health and Nutrition-Site Number: 8400136

Des Plaines, Illinois, 60016, United States

RECRUITING

GI Alliance - Glenview - Site Number: 8400068

Glenview, Illinois, 60031, United States

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Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049

Gurnee, Illinois, 60031, United States

RECRUITING

Gastroenterology Health Partners, PLLC - Site Number: 8400100

New Albany, Indiana, 47150, United States

RECRUITING

Cedar Valley Digestive Health Center-Site Number: 8400096

Waterloo, Iowa, 50701, United States

RECRUITING

GI Alliance - Baton Rouge - Site Number: 8400129

Baton Rouge, Louisiana, 70809, United States

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Tandem Intermediate, LLC - Houma-Site Number: 8400034

Houma, Louisiana, 70360, United States

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Gastro Group-Site Number: 8400128

Mandeville, Louisiana, 70471, United States

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Tandem Clinical Research - Marrero-Site Number: 8400002

Marrero, Louisiana, 70072, United States

RECRUITING

GI Alliance - Metairie-Site Number: 8400124

Metairie, Louisiana, 70006, United States

RECRUITING

Delta Research Partners-Site Number: 8400087

Monroe, Louisiana, 71291, United States

RECRUITING

Care Access - New Iberia-Site Number: 8400031

New Iberia, Louisiana, 70560, United States

RECRUITING

Mid-Atlantic GI Research, LLC - Site Number: 8400106

Greenbelt, Maryland, 20770, United States

RECRUITING

UMass Memorial Medical Center-Site Number: 8400121

Worcester, Massachusetts, 01655, United States

RECRUITING

Gastroenterology Associates of Western Michigan - Site Number: 8400060

Wyoming, Michigan, 49519, United States

RECRUITING

Allied Health Clinical Research Organization, LLC - Jackson-Site Number: 8400007

Jackson, Mississippi, 08527, United States

RECRUITING

Gateway Gastroenterology: 8400097

Chesterfield, Missouri, 63017, United States

RECRUITING

BVL Clinical Research: 8400005

Liberty, Missouri, 64068, United States

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Las Vegas Clinical Trials- Site Number: 8400079

Las Vegas, Nevada, 89030, United States

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Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123

East Orange, New Jersey, 07018, United States

RECRUITING

Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014

Freehold, New Jersey, 07728, United States

RECRUITING

Tandem-Allied Clinical Research - Somers Point- Site Number: 8400050

Somers Point, New Jersey, 08244, United States

RECRUITING

Premier Health Research, LLC - Site Number: 8400114

Sparta, New Jersey, 07871, United States

RECRUITING

MedTraits NY-Site Number: 8400045

Maspeth, New York, 11378, United States

RECRUITING

Manhattan Clinical Research, LLC - Site Number: 8400069

New York, New York, 10016, United States

RECRUITING

NYU Langone Health- Site Number: 8400091

New York, New York, 10016, United States

RECRUITING

Weill Cornell Medical College - NewYork-Presbyterian Hospital-Site Number: 8400040

New York, New York, 10065, United States

RECRUITING

New York Gastroenterology Associates-Site Number: 8400009

New York, New York, 10075, United States

RECRUITING

UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074

Chapel Hill, North Carolina, 27514, United States

RECRUITING

OnSite Clinical Solutions-Site Number: 8400051

Charlotte, North Carolina, 28211, United States

RECRUITING

Cross Creek Medical Clinic-Site Number: 8400057

Fayetteville, North Carolina, 28304, United States

RECRUITING

Monroe Biomedical Research - Site Number: 8400046

Monroe, North Carolina, 28112, United States

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ClinTrial Research, LLC - Site Number: 8400043

Raleigh, North Carolina, 27612, United States

RECRUITING

Plains Medical Clinic-Site Number: 8400078

Fargo, North Dakota, 58104, United States

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Gastroenterology & Hepatology Specialists, Inc.-Site Number: 8400139

Canton, Ohio, 44718, United States

RECRUITING

Ohio Gastroenterology Group Inc.: 8400006

Columbus, Ohio, 43202, United States

RECRUITING

OSU Wexner Medical Center- Site Number: 8400077

Columbus, Ohio, 43210, United States

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DSI Research, LLC-Site Number: 8400115

Dayton, Ohio, 45414, United States

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DSI Research, LLC - Site Number: 8400105

Springboro, Ohio, 45066, United States

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North Shore Gastroenterology Research - Site Number: 8400130

Westlake, Ohio, 44145, United States

RECRUITING

Central Sooner Research-Site Number: 8400094

Norman, Oklahoma, 73071, United States

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University of Pennsylvania School of Medicine- Site Number: 8400072

Philadelphia, Pennsylvania, 19104-6243, United States

RECRUITING

The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University Gastroenterology - GI Alliance - Site Number: 8400103

Providence, Rhode Island, 02904, United States

RECRUITING

Biocentric Health Research Partner-Site Number: 8400089

West Columbia, South Carolina, 29169, United States

RECRUITING

Tri-Cities Gastroenterology-Site Number: 8400076

Kingsport, Tennessee, 37663, United States

RECRUITING

Valley Institute of Research: 8400004

Harlingen, Texas, 78550, United States

RECRUITING

One of a Kind Clinical Research Center LLC - Texas-Site Number: 8400125

Kingwood, Texas, 77339, United States

RECRUITING

Innovare Research Group-Site Number: 8400067

Lake Jackson, Texas, 77566, United States

RECRUITING

Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092

Lubbock, Texas, 79410, United States

RECRUITING

SMS Clinical Research-Site Number: 8400035

Mesquite, Texas, 75149, United States

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Gastroenterology Research of San Antonio LLC-Site Number: 8400054

San Antonio, Texas, 78229, United States

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Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101

Southlake, Texas, 76092, United States

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Texas Gastro Consultants: 8400029

Tomball, Texas, 77375, United States

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Tyler Research Institute, LLC: 8400095

Tyler, Texas, 75701, United States

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Blue Ridge Medical Research: 8400020

Lynchburg, Virginia, 24502, United States

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Clinical Research Partners - Site Number: 8400080

Richmond, Virginia, 23226, United States

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The Vancouver Clinic Inc. P.S. - Site Number: 8400090

Vancouver, Washington, 98664, United States

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Investigational Site Number : 0360001

South Brisbane, 4101, Australia

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Investigational Site Number : 0400004

Graz, Styria, 8036, Austria

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Investigational Site Number : 0400005

Linz, Upper Austria, 4021, Austria

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Investigational Site Number : 0400002

Salzburg, 5020, Austria

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Investigational Site Number : 0400001

Vienna, 1090, Austria

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Investigational Site Number : 0400007

Vienna, 1190, Austria

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Investigational Site Number : 1000007

Rousse, 7002, Bulgaria

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Investigational Site Number : 1000008

Sofia, 1343, Bulgaria

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Investigational Site Number : 1000001

Sofia, 1618, Bulgaria

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Investigational Site Number: 1240009

Hamilton, L8N 1Y2, Canada

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Investigational Site Number : 1240013

London, N6K 1M6, Canada

RECRUITING

Investigational Site Number: 1240010

Oakville, L6L 5L7, Canada

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Investigational Site Number: 1240003

Toronto, M6A 3B4, Canada

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Investigational Site Number : 1560002

Guangzhou, Guangdong, China

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Investigational Site Number : 2030011

Hradec Králové, 500 12, Czechia

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Investigational Site Number : 2030013

Prague, 150 00, Czechia

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Investigational Site Number : 2680007

Kutaisi, 4600, Georgia

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Investigational Site Number : 2680006

Tbilisi, 102, Georgia

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Investigational Site Number : 2680008

Tbilisi, 144, Georgia

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Investigational Site Number : 2680003

Tbilisi, 159, Georgia

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Investigational Site Number : 2680005

Tbilisi, 160, Georgia

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Investigational Site Number : 2680002

Tbilisi, 180, Georgia

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Investigational Site Number : 2680004

Tbilisi, 180, Georgia

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Investigational Site Number : 2760005

Ulm, Baden-Wurttemberg, 89081, Germany

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Investigational Site Number : 2760015

Leipzig, Saxony, 4103, Germany

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Investigational Site Number : 2760003

Berlin, Berlin, Germany

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Investigational Site Number : 2760019

Dachau, 85221, Germany

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Investigational Site Number : 2760026

Herne, 44623, Germany

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Investigational Site Number : 2760001

Kiel, 24105, Germany

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Investigational Site Number : 2760010

Minden, 32423, Germany

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Investigational Site Number : 3480004

Budapest, 1066, Hungary

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Investigational Site Number : 3480001

Veszprém, 8200, Hungary

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Investigational Site Number : 3920005

Asahikawa, 078-8510, Japan

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Investigational Site Number : 3920059

Bunkyō City, 113-8655, Japan

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Investigational Site Number : 3920039

Chikushino-shi, 818-8502, Japan

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Investigational Site Number : 3920027

Fukuoka, 815-8555, Japan

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-Site Number : 3920028

Isesaki, 372-0817, Japan

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Kagoshima IBD Gastroenterology Clinic Site Number : 3920049

Kagoshima, 892-0843, Japan

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Ofuna Chuo Hospital: 3920029

Kamakura, 247-0056, Japan

RECRUITING

Kokikai Tsujinaka Hospital Kashiwanoha: 3920031

Kashiwa, 277-0871, Japan

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Aoyama Clinic-Site Number: 3920018

Kobe, 650-0015, Japan

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Investigational Site Number : 3920036

Kumamoto, 862-0971, Japan

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Investigational Site Number : 3920050

Osaka, 532-0003, Japan

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National Hospital Organization Osaka National Hospital-Site Number : 3920002

Osaka, 540-0006, Japan

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Investigational Site Number : 3920014

Saga, 849-8501, Japan

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Investigational Site Number : 3920023

Sakura, 285-8741, Japan

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Sapporo Tokushukai Hospital-Site Number: 3920019

Sapporo, 004-0041, Japan

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-Site Number : 3920042

Sapporo, 065-0033, Japan

RECRUITING

Investigational Site Number : 3920004

Sendai, 981-3213, Japan

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National Hospital Organization Sendai Medical Center-Site Number : 3920003

Sendai, 983-8520, Japan

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Investigational Site Number : 3920020

Shiwa-gun, 028-3695, Japan

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Tokai University Hachioji Hospital: 3920030

Tokyo, 192-0032, Japan

RECRUITING

Toyama University Hospital: 3920032

Toyama, 930-0194, Japan

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Investigational Site Number : 3920037

Toyama, 930-8550, Japan

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Investigational Site Number : 3920015

Toyohashi, 441-8570, Japan

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Mie University Hospital-Site Number : 3920009

Tsu, 514-8507, Japan

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Investigational Site Number : 4980002

Chisinau, MD-2025, Moldova

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Investigational Site Number : 4980003

Chisinau, MD-2025, Moldova

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Investigational Site Number : 4980004

Chisinau, MD-2068, Moldova

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Investigational Site Number : 6160013

Elblag, 82-300, Poland

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Investigational Site Number : 6160014

Katowice, 40-748, Poland

RECRUITING

Investigational Site Number : 6160022

Krakow, 31-506, Poland

RECRUITING

Investigational Site Number : 6160030

Kłodzko, 57-300, Poland

RECRUITING

Investigational Site Number : 6160016

Lodz, 90-752, Poland

RECRUITING

Investigational Site Number : 6160011

Lodz, 91-034, Poland

RECRUITING

Investigational Site Number : 6160018

Poznan, 60-309, Poland

RECRUITING

Investigational Site Number : 6160025

Rzeszów, 35-326, Poland

RECRUITING

Investigational Site Number : 6160004

Sopot, 81-756, Poland

RECRUITING

Investigational Site Number : 6160007

Staszów, 28-200, Poland

RECRUITING

Investigational Site Number : 6160002

Szczecin, 71-434, Poland

RECRUITING

Investigational Site Number : 6160020

Szczecin, 71-685, Poland

RECRUITING

Investigational Site Number : 6160012

Wadowice, 34-100, Poland

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Investigational Site Number : 6160005

Warsaw, 00-189, Poland

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Investigational Site Number : 6160031

Warsaw, 01-595, Poland

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Investigational Site Number : 6160006

Wroclaw, 52-416, Poland

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Investigational Site Number : 6160028

Wroclaw, 53-611, Poland

RECRUITING

Wellness Clinical Research - Vega Baja: 8400099

Vega Baja, 00693, Puerto Rico

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Investigational Site Number : 6880001

Belgrade, 11,000, Serbia

RECRUITING

Investigational Site Number : 6880002

Belgrade, 11,000, Serbia

RECRUITING

Investigational Site Number : 6880006

Belgrade, 11000, Serbia

RECRUITING

Investigational Site Number : 6880007

Belgrade, 11000, Serbia

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Investigational Site Number : 6880004

Niš, 18,000, Serbia

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Investigational Site Number : 7030001

Bratislava, 811 09, Slovakia

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Investigational Site Number : 7030003

Košice, 040 13, Slovakia

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Investigational Site Number : 7100005

Claremont, 7708, South Africa

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Investigational Site Number : 7100004

Durban, 3610, South Africa

RECRUITING

Investigational Site Number : 7100001

Kempton Park, 1619, South Africa

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Investigational Site Number : 4100003

Daejeon, 34943, South Korea

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Investigational Site Number : 4100005

Suwon, 16247, South Korea

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Investigational Site Number : 7560002

Basel, CH-4058, Switzerland

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Investigational Site Number : 7560001

Bern, 3012, Switzerland

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Investigational Site Number : 1560003

Chiayi City, 60002, Taiwan

RECRUITING

Investigational Site Number : 1580003

Chiayi City, 60002, Taiwan

RECRUITING

Investigational Site Number : 1580002

Taipei, 100226, Taiwan

RECRUITING

Investigational Site Number : 8040003

Chernivtsi, 58001, Ukraine

RECRUITING

Investigational Site Number : 8040001

Kyiv, 2002, Ukraine

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Investigational Site Number : 8040013

Kyiv, 2091, Ukraine

RECRUITING

Investigational Site Number : 8040002

Kyiv, 3037, Ukraine

RECRUITING

Investigational Site Number : 8040004

Lviv, 79000, Ukraine

RECRUITING

Investigational Site Number : 8040005

Lviv, 79000, Ukraine

RECRUITING

Investigational Site Number : 8040011

Lviv, 79010, Ukraine

RECRUITING

Investigational Site Number : 8040006

Uzhhorod, 88000, Ukraine

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Investigational Site Number : 8040010

Vinnytsia, 21013, Ukraine

RECRUITING

Investigational Site Number : 8040009

Vinnytsia, 21028, Ukraine

RECRUITING

Investigational Site Number : 8040008

Vinnytsia, 21029, Ukraine

RECRUITING

Related Links

• EFC18326 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 3
• 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: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 14, 2029
• Study Completion (Estimated): May 14, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1); DE (7); SE (5); SL (2); CZ (2); HU (2); PL (17); AU (5); BU (3); KR (2); PR (1); TW (3); CH (2); US (91); CA (4); ZA (3); GE (7); UA (11); MO (3); JP (24)