A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Purpose

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: - 40-week Pivotal Maintenance Sub-Study - 240-week Open-Label Extension (OLE) Sub-Study - 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: - 40 weeks in the Pivotal Maintenance Sub-Study - 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

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 Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development) - Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1 - OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion Criteria

  • Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator - Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator The above information is not intended to contain all considerations relevant to a patient'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
Du vakitug dose 2 		SC injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form:Injection solution-Route of administration:SC injection
    Other names:
    • SAR447189
Experimental
Du vakitug dose 3 		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

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

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

Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida 33175

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

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

Gateway Gastroenterology-Site Number: 8400097
St Louis, Missouri 63141

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

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

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

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

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

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

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