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RecruitingPhase 3

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

Sanofi · with Teva Branded Pharmaceutical Products R&D LLC · NCT07184944

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
751
US sites recruiting
34
Study start
January 22, 2026
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Duvakitug; Placebo

Conditions: Crohn's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

    Colorado Springs, CO 80907

  • Clinical Research of Osceola-Site Number: 8400013

    Kissimmee, FL 34741

  • Columbus Clinical Services LLc-Site Number: 8400038

    Miami, FL 33125

  • Bioresearch Partner-Kendale Lakes-Site Number: 8400053

    Miami, FL 33175

  • Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084

    Orlando, FL 32806

  • NMC Research LLC-Site Number: 8400033

    Tampa, FL 33607

  • Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049

    Gurnee, IL 60031

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

    New Albany, IN 47150

  • GI Alliance - Baton Rouge-Site Number: 8400129

    Baton Rouge, LA 70809

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

    Mandeville, LA 70471

  • GI Alliance - Metairie-Site Number: 8400124

    Metairie, LA 70006

  • Delta Research Partners-Site Number: 8400087

    Monroe, LA 71291

  • BVL Clinical Research-Site Number: 8400005

    Liberty, MO 64068

  • Gateway Gastroenterology-Site Number: 8400097

    St Louis, MO 63141

  • MedTraits NY-Site Number: 8400045

    Maspeth, NY 11378

  • NYU Langone Health-Site Number: 8400091

    New York, NY 10016

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

    New York, NY 10065

  • New York Gastroenterology Associates-Site Number: 8400009

    New York, NY 10075

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

    Chapel Hill, NC 27514

  • Cross Creek Medical Clinic-Site Number: 8400057

    Fayetteville, NC 28304

  • Ohio Gastroenterology Group Inc.-Site Number: 8400006

    Columbus, OH 43202

  • Medical Associates Research Group-Site Number: 8400063

    Columbus, OH 43210

  • OSU Wexner Medical Center-Site Number: 8400077

    Columbus, OH 43210

  • North Shore Gastroenterology Research-Site Number: 8400130

    Westlake, OH 44145

  • University of Pennsylvania School of Medicine-Site Number: 8400072

    Philadelphia, PA 19104-6243

  • The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107

    Pittsburgh, PA 15212

  • University Gastroenterology - GI Alliance-Site Number: 8400103

    Providence, RI 02904

  • GI Alliance - Lubbock-Site Number: 8400092

    Lubbock, TX 79410

  • SMS Clinical Research-Site Number: 8400035

    Mesquite, TX 75149

  • Gastroenterology Research of San Antonio LLC-Site Number: 8400054

    San Antonio, TX 78229

  • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101

    Southlake, TX 76092

  • Tyler Research Institute LLC-Site Number: 8400095

    Tyler, TX 75701

  • The Vancouver Clinic Inc. P.S.-Site Number: 8400090

    Vancouver, WA 98664

  • Gastroenterology Associates of Western Michigan-Site Number: 8400060

    Wyoming, WY 49519

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
A Maintenance Study to Investigate the Efficacy and Safety of… (NCT07184944) | Bored Studies