Recruiting

Phase 3

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

Sponsor:

Sanofi

Code:

NCT07184944

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Duvakitug

Placebo

Study Details

Brief summary:

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

Conditions

Crohn's Disease

Study ID

NCT07184944

Start date

Jan 22, 2026

Status verified date

Jun, 2026

Completion date

Mar 20, 2034

Anticipated

Primary completion date

Aug 13, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

751 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Duvakitug dose 1

Subcutaneous (SC) injection as per protocol

experimental: Du vakitug dose 2

SC injection as per protocol

experimental: Du vakitug dose 3

SC injection as per protocol

placebo comparator: Placebo

SC injection as per protocol

Interventions

Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

Placebo

Pharmaceutical form:Injection solution-Route of administration:SC injection

Primary outcome measure

Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40 [ Time Frame: Week 40 ]
Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40 [ Time Frame: Week 40 ]
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40 [ Time Frame: Week 40 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610 Contact-US@sanofi.com

Locations

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

Recruiting

Colorado Springs, Colorado, United States, 80907

Clinical Research of Osceola-Site Number: 8400013

Recruiting

Kissimmee, Florida, United States, 34741

Bioresearch Partner-Kendale Lakes-Site Number: 8400053

Recruiting

Miami, Florida, United States, 33175

NMC Research LLC-Site Number: 8400033

Recruiting

Tampa, Florida, United States, 33607

Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100

Recruiting

New Albany, Indiana, United States, 47150

GI Alliance - Baton Rouge-Site Number: 8400129

Recruiting

Baton Rouge, Louisiana, United States, 70809

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128

Recruiting

Mandeville, Louisiana, United States, 70471

Gateway Gastroenterology-Site Number: 8400097

Recruiting

St Louis, Missouri, United States, 63141

MedTraits NY-Site Number: 8400045

Recruiting

Maspeth, New York, United States, 11378

NYU Langone Health-Site Number: 8400091

Recruiting

New York, New York, United States, 10016

Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040

Recruiting

New York, New York, United States, 10065

New York Gastroenterology Associates-Site Number: 8400009

Recruiting

New York, New York, United States, 10075

UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074

Recruiting

Chapel Hill, North Carolina, United States, 27514

Cross Creek Medical Clinic-Site Number: 8400057

Recruiting

Fayetteville, North Carolina, United States, 28304

Ohio Gastroenterology Group Inc.-Site Number: 8400006

Recruiting

Columbus, Ohio, United States, 43202

OSU Wexner Medical Center-Site Number: 8400077

Recruiting

Columbus, Ohio, United States, 43210

North Shore Gastroenterology Research-Site Number: 8400130

Recruiting

Westlake, Ohio, United States, 44145

University of Pennsylvania School of Medicine-Site Number: 8400072

Recruiting

Philadelphia, Pennsylvania, United States, 19104-6243

GI Alliance - Lubbock-Site Number: 8400092

Recruiting

Lubbock, Texas, United States, 79410

Gastroenterology Research of San Antonio LLC-Site Number: 8400054

Recruiting

San Antonio, Texas, United States, 78229

Tyler Research Institute LLC-Site Number: 8400095

Recruiting

Tyler, Texas, United States, 75701

Gastroenterology Associates of Western Michigan-Site Number: 8400060

Recruiting

Wyoming, Wyoming, United States, 49519

Investigational Site Number : 1240009

Recruiting

Hamilton, Canada, L8N 1Y2

Investigational Site Number : 1240003

Recruiting

Toronto, Canada, M6A 3B4

More Information

Sponsor

Sanofi

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-06-22.