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 5308480, Arizona 5551752 85381

Del Sol Research Management, LLC - Site Number: 8400012
Tucson 5318313, Arizona 5551752 85715

Preferred Research Partners - Site Number: 8400018
Little Rock 4119403, Arkansas 4099753 72211

FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia 5324477, California 5332921 91006

Alliance Research Institute - Site Number: 8400008
Canoga Park 5333913, California 5332921 91304

Southern California GI & Liver Centers - Site Number: 8400062
Coronado 5339663, California 5332921 92118-1408

GMC Clinical Research, LLC - Site Number: 8400113
Folsom 5349705, California 5332921 95630

TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles 5368361, California 5332921 90048

United Medical Doctors CA - Site Number: 8400044
Murrieta 5375911, California 5332921 92563

Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria 5393180, California 5332921 93458

Valiance Clinical Research - Tarzana - Site Number: 8400023
Tarzana 5401143, California 5332921 91356

Clinical Trials Management Services - Site Number: 8400047
Thousand Oaks 5402405, California 5332921 91360

Amicis Research Center-Valencia -Site Number: 8400064
Valencia 5405288, California 5332921 91355

Om Research, LLC - Victorville - Site Number: 8400022
Victorville 5406222, California 5332921 92395

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs 5417598, Colorado 5417618 80907

Precision Clinical Research-Site Number: 8400059
Coral Springs 4151909, Florida 4155751 33065

Sarkis Clinical Trials-Ocala - Site Number: 8400048
Gainesville 4156404, Florida 4155751 32607

Clinical Research of Osceola - Site Number: 8400013
Kissimmee 4160983, Florida 4155751 34741

Columbus Clinical Services LLc - Site Number: 8400038
Miami 4164138, Florida 4155751 33125

Regis Clinical Research, LLC - Site Number: 8400041
Miami 4164138, Florida 4155751 33126

Bio Research Partner - Site Number: 8400053
Miami 4164138, Florida 4155751 33155

Correa Research Center-Site Number: 8400010
Miami 4164138, Florida 4155751 33186

NMC Research LLC - Site Number: 8400033
Tampa 4174757, Florida 4155751 33607

M3 Wake Research - Atlanta - Site Number: 8400028
Sandy Springs 4221333, Georgia 4197000 30328

EBGS Clinical Research Center, LLC - Site Number: 8400037
Snellville 4223413, Georgia 4197000 30078

GI Alliance - Glenview - Site Number: 8400068
Glenview 4893886, Illinois 4896861 60026

Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
Gurnee 4894861, Illinois 4896861 60031

Gastroenterology Health Partners, PLLC - Site Number: 8400100
New Albany 4262045, Indiana 4921868 47150

GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge 4315588, Louisiana 4331987 70809

GI Alliance - Metairie - Site Number: 8400124
Metairie 4333177, Louisiana 4331987 70006

Delta Research Partners
Monroe 4333669, Louisiana 4331987 71291

Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt 4356847, Maryland 4361885 20770

Gastroenterology Associates of Western Michigan - Site Number: 8400060
Wyoming 5015618, Michigan 5001836 49519

Gateway Gastroenterology - Site Number: 8400097
Chesterfield 4381072, Missouri 4398678 63017

BVL Clinical Research - Site Number: 8400005
Liberty 4395052, Missouri 4398678 64068

Premier Health Research, LLC - Site Number: 8400114
Sparta 5104882, New Jersey 5101760 07871

MedTraits NY - Site Number: 8400045
Maspeth 5126180, New York 5128638 11378

Manhattan Clinical Research, LLC - Site Number: 8400069
New York 5128581, New York 5128638 10016

New York Gastroenterology Associates - Site Number: 8400009
New York 5128581, New York 5128638 10075

OnSite Clinical Solutions - Site Number: 8400051
Charlotte 4460243, North Carolina 4482348 28211

Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville 4466033, North Carolina 4482348 28304

Monroe Biomedical Research - Site Number: 8400046
Monroe 4479946, North Carolina 4482348 28112

ClinTrial Research, LLC - Site Number: 8400043
Raleigh 4487042, North Carolina 4482348 27612

Plains Medical Clinic - Site Number: 8400078
Fargo 5059163, North Dakota 5690763 58104

Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus 4509177, Ohio 5165418 43202

DSI Research, LLC - Site Number: 8400115
Dayton 4509884, Ohio 5165418 45414

DSI Research, LLC - Site Number: 8400105
Springboro 4525304, Ohio 5165418 45066

North Shore Gastroenterology Research - Site Number: 8400130
Westlake 5176517, Ohio 5165418 44145

Central Sooner Research - Site Number: 8400094
Norman 4543762, Oklahoma 4544379 73071

University Gastroenterology - GI Alliance - Site Number: 8400103
Providence 5224151, Rhode Island 5224323 02904

Biocentric Health Research Partner
West Columbia 4600541, South Carolina 4597040 29169

Valley Institute of Research - Site Number: 8400004
Harlingen 4696233, Texas 4736286 78550

Innovare Research Group - Site Number: 8400067
Lake Jackson 4704628, Texas 4736286 77566

Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
Lubbock 5525577, Texas 4736286 79410

Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
Southlake 4733313, Texas 4736286 76092

Texas Gastro Consultants - Site Number: 8400029
Tomball 4737094, Texas 4736286 77375

Tyler Research Institute, LLC - Site Number: 8400095
Tyler 4738214, Texas 4736286 75701

Blue Ridge Medical Research - Site Number: 8400020
Lynchburg 4771075, Virginia 6254928 24502

Clinical Research Partners - Site Number: 8400080
Richmond 4781708, Virginia 6254928 23226

The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver 5814616, Washington 5815135 98664

Wellness Clinical Research - Vega Baja - Site Number: 8400099
Vega Baja 4568533, 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