Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.