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

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

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

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

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

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

Delta Research Partners
Monroe 4333669, Louisiana 4331987 71291

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

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

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

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

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

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

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

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

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

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

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

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