An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Purpose

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: - 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) - 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Condition

  • Ulcerative Colitis

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 UC for at least 3 months prior to Baseline - Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion Criteria

  • Participants with Crohn's Disease (CD), indeterminate colitis - Current diagnosis of Ulcerative Proctitis - Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections - Prior or current high-grade gastrointestinal (GI) dysplasia - Participants on treatment with but not on stable doses of conventional therapies prior to baseline - Participants with prohibited medications or therapies prior to baseline - 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:Solution for Injection-Route of administration:SC injection
    Other names:
    • SAR447189
Experimental
Duvakitug - dose 2 		SC injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form:Solution for Injection-Route of administration:SC injection
    Other names:
    • SAR447189
Placebo Comparator
Placebo 		SC injection as per protocol
  • Drug: Placebo
    Pharmaceutical form:Solution for injection-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 - Site Number: 8400018
Little Rock, Arkansas 72211

FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, California 91006

Alliance Research Institute - 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. - Site Number: 8400030
Los Angeles, California 90048

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

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

Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria, California 93458

Valiance Clinical Research - Tarzana - Site Number: 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 32803

Precision Clinical Research-Site Number: 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 - Site Number: 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 60026

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 70072

GastroGroup - 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
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

Gateway Gastroenterology - Site Number: 8400097
Chesterfield, Missouri 63017

BVL Clinical Research - Site Number: 8400005
Liberty, Missouri 64068

Las Vegas Clinical Trials - Site Number: 8400079
Las Vegas, Nevada 89128

SMS Clinical Research - Site Number: 8400035
Mesquite, Nevada 75043

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

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

Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
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. - Site Number: 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

The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107
Pittsburgh, Pennsylvania 15212

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

Biocentric Health Research Partner
West Columbia, South Carolina 29169

Valley Institute of Research - Site Number: 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

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 - Site Number: 8400029
Tomball, Texas 77375

Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas 75701

Blue Ridge Medical Research - Site Number: 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 - Site Number: 8400099
Vega Baja, Puerto Rico 00693

More Details

NCT ID
NCT07184996
Status
Recruiting
Sponsor
Sanofi

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center