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

Purpose

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.

Condition

  • Crohn's Disease

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Duvakitug Dose 1 		Subcutaneous (SC) Injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form:Injection solution Route of administration:SC injection
    Other names:
    • SAR447189
Experimental
Duvakitug Dose 2 		SC injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form:Injection solution Route of administration:SC injection
    Other names:
    • SAR447189
Placebo Comparator
Placebo 		SC injection as per protocol
  • Drug: Placebo
    Pharmaceutical form:Injection solution Route of administration:SC injection

Recruiting Locations

Onyx Clinical Research - Site Number: 8400021
Peoria, Arizona 85381

One of a Kind Clinical Research Center LLC-Site Number: 8400061
Scottsdale, Arizona 85258

Del Sol Research Management, LLC-Site Number: 8400012
Tucson, Arizona 85715

Preferred Research Partners: 8400018
Little Rock, Arkansas 72211

Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008
Canoga Park, California 91304

Southern California GI & Liver Centers-Site Number: 8400062
Coronado, California 92118-1408

GMC Clinical Research, LLC-Site Number: 8400113
Folsom, California 95630

TLC Clinical Research Inc.: 8400030
Los Angeles, California 90048

United Medical Doctors CA-Site Number: 8400044
Murrieta, California 92563

Prospective Research Innovations Inc.: 8400017
Rancho Cucamonga, California 91730

Medical Associates Research Group-Site Number: 8400063
San Diego, California 92123

Valiance Clinical Research - Tarzana: 8400023
Tarzana, California 91356

Clinical Trials Management Services-Site Number: 8400047
Thousand Oaks, California 91360

Amicis Research Center-Valencia-Site Number: 8400064
Valencia, California 91355

Om Research, LLC - Victorville - Site Number: 8400022
Victorville, California 92395

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado 80907

Gastroenterology of the Rockies - Denver-Site Number: 8400122
Denver, Colorado 80218

Novum Research, LLC-Site Number: 8400003
Clermont, Florida 34711

Precision Clinical Research: 8400059
Coral Springs, Florida 33065

Sarkis Clinical Trials-Ocala-Site Number: 8400048
Gainesville, Florida 32607

Clinical Research of Osceola-Site Number: 8400013
Kissimmee, Florida 34741

Columbus Clinical Services LLc-Site Number: 8400038
Miami, Florida 33125

Regis Clinical Research, LLC-Site Number: 8400041
Miami, Florida 33126

Bio Research Partner-Site Number: 8400053
Miami, Florida 33155

Medical Professional Clinical Research Center-Site Number: 8400119
Miami, Florida 33165

Correa Research Center-Site Number: 8400010
Miami, Florida 33186

Orlando Health, Inc.-Site Number: 8400084
Orlando, Florida 32806

Tropical Clinical Trials-Site Number: 8400082
Palmetto Bay, Florida 33176

NMC Research LLC - Site Number: 8400033
Tampa, Florida 33607

Atlanta Gastroenterology Associates-Site Number: 8400109
Atlanta, Georgia 30342

M3 Wake Research - Atlanta: 8400028
Sandy Springs, Georgia 30328

EBGS Clinical Research Center, LLC-Site Number 8400037
Snellville, Georgia 30078

Grand Teton Research Group, PLLC-Site Number: 8400127
Idaho Falls, Idaho 83404

Midwest Digestive Health and Nutrition-Site Number: 8400136
Des Plaines, Illinois 60016

GI Alliance - Glenview - Site Number: 8400068
Glenview, Illinois 60031

Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
Gurnee, Illinois 60031

Gastroenterology Health Partners, PLLC - Site Number: 8400100
New Albany, Indiana 47150

Cedar Valley Digestive Health Center-Site Number: 8400096
Waterloo, Iowa 50701

GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana 70809

Tandem Intermediate, LLC - Houma-Site Number: 8400034
Houma, Louisiana 70360

Gastro Group-Site Number: 8400128
Mandeville, Louisiana 70471

Tandem Clinical Research - Marrero-Site Number: 8400002
Marrero, Louisiana 70072

GI Alliance - Metairie-Site Number: 8400124
Metairie, Louisiana 70006

Delta Research Partners-Site Number: 8400087
Monroe, Louisiana 71291

Care Access - New Iberia-Site Number: 8400031
New Iberia, Louisiana 70560

Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt, Maryland 20770

UMass Memorial Medical Center-Site Number: 8400121
Worcester, Massachusetts 01655

Gastroenterology Associates of Western Michigan - Site Number: 8400060
Wyoming, Michigan 49519

Allied Health Clinical Research Organization, LLC - Jackson-Site Number: 8400007
Jackson, Mississippi 08527

Gateway Gastroenterology: 8400097
Chesterfield, Missouri 63017

BVL Clinical Research: 8400005
Liberty, Missouri 64068

Las Vegas Clinical Trials- Site Number: 8400079
Las Vegas, Nevada 89030

Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123
East Orange, New Jersey 07018

Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014
Freehold, New Jersey 07728

Tandem-Allied Clinical Research - Somers Point- Site Number: 8400050
Somers Point, New Jersey 08244

Premier Health Research, LLC - Site Number: 8400114
Sparta, New Jersey 07871

MedTraits NY-Site Number: 8400045
Maspeth, New York 11378

Manhattan Clinical Research, LLC - Site Number: 8400069
New York, New York 10016

NYU Langone Health- Site Number: 8400091
New York, New York 10016

Weill Cornell Medical College - NewYork-Presbyterian Hospital-Site Number: 8400040
New York, New York 10065

New York Gastroenterology Associates-Site Number: 8400009
New York, New York 10075

UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
Chapel Hill, North Carolina 27514

OnSite Clinical Solutions-Site Number: 8400051
Charlotte, North Carolina 28211

Cross Creek Medical Clinic-Site Number: 8400057
Fayetteville, North Carolina 28304

Monroe Biomedical Research - Site Number: 8400046
Monroe, North Carolina 28112

ClinTrial Research, LLC - Site Number: 8400043
Raleigh, North Carolina 27612

Plains Medical Clinic-Site Number: 8400078
Fargo, North Dakota 58104

Gastroenterology & Hepatology Specialists, Inc.-Site Number: 8400139
Canton, Ohio 44718

Ohio Gastroenterology Group Inc.: 8400006
Columbus, Ohio 43202

OSU Wexner Medical Center- Site Number: 8400077
Columbus, Ohio 43210

DSI Research, LLC-Site Number: 8400115
Dayton, Ohio 45414

DSI Research, LLC - Site Number: 8400105
Springboro, Ohio 45066

North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio 44145

Central Sooner Research-Site Number: 8400094
Norman, Oklahoma 73071

University of Pennsylvania School of Medicine- Site Number: 8400072
Philadelphia, Pennsylvania 19104-6243

University Gastroenterology - GI Alliance - Site Number: 8400103
Providence, Rhode Island 02904

Biocentric Health Research Partner-Site Number: 8400089
West Columbia, South Carolina 29169

Tri-Cities Gastroenterology-Site Number: 8400076
Kingsport, Tennessee 37663

Valley Institute of Research: 8400004
Harlingen, Texas 78550

One of a Kind Clinical Research Center LLC - Texas-Site Number: 8400125
Kingwood, Texas 77339

Innovare Research Group-Site Number: 8400067
Lake Jackson, Texas 77566

Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
Lubbock, Texas 79410

SMS Clinical Research-Site Number: 8400035
Mesquite, Texas 75149

Gastroenterology Research of San Antonio LLC-Site Number: 8400054
San Antonio, Texas 78229

Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
Southlake, Texas 76092

Texas Gastro Consultants: 8400029
Tomball, Texas 77375

Tyler Research Institute, LLC: 8400095
Tyler, Texas 75701

Blue Ridge Medical Research: 8400020
Lynchburg, Virginia 24502

Clinical Research Partners - Site Number: 8400080
Richmond, Virginia 23226

The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver, Washington 98664

Wellness Clinical Research - Vega Baja: 8400099
Vega Baja, Puerto Rico 00693

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com