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

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

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

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

Prospective Research Innovations Inc.: 8400017
Rancho Cucamonga 5385955, California 5332921 91730

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

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

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

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

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

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

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

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

Bio Research Partner: 8400053
Miami 4164138, Florida 4155751 33155

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

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

Delta Research Partners: 8400087
Monroe 4333669, Louisiana 4331987 71291

Gateway Gastroenterology: 8400097
Chesterfield 4381072, Missouri 4398678 63017

BVL Clinical Research: 8400005
Liberty 4395052, Missouri 4398678 64068

MedTraits NY: 8400045
Maspeth 5126180, New York 5128638 11378

New York Gastroenterology Associates: 8400009
New York 5128581, New York 5128638 10075

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

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

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

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

Central Sooner Research: 8400094
Norman 4543762, Oklahoma 4544379 73071

Biocentric Health Research Partner: 8400089
West Columbia 4600541, South Carolina 4597040 29169

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

Tyler Research Institute, LLC: 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