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

NCT07184944

This study is recruiting at 34 US sites in 14 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Crohn's Disease

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
16 to 80 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Sanofi
Last updated on ClinicalTrials.gov
September 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Colorado · 1

  • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 · Colorado Springs, CO

Florida · 5

  • Clinical Research of Osceola-Site Number: 8400013 · Kissimmee, FL
  • Bioresearch Partner-Kendale Lakes-Site Number: 8400053 · Miami, FL
  • Columbus Clinical Services LLc-Site Number: 8400038 · Miami, FL
  • Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084 · Orlando, FL
  • NMC Research LLC-Site Number: 8400033 · Tampa, FL

Illinois · 1

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

Indiana · 1

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

Louisiana · 4

  • GI Alliance - Baton Rouge-Site Number: 8400129 · Baton Rouge, LA
  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 · Mandeville, LA
  • GI Alliance - Metairie-Site Number: 8400124 · Metairie, LA
  • Delta Research Partners-Site Number: 8400087 · Monroe, LA

Missouri · 2

  • BVL Clinical Research-Site Number: 8400005 · Liberty, MO
  • Gateway Gastroenterology-Site Number: 8400097 · St Louis, MO

New York · 4

  • MedTraits NY-Site Number: 8400045 · Maspeth, NY
  • New York Gastroenterology Associates-Site Number: 8400009 · New York, NY
  • NYU Langone Health-Site Number: 8400091 · New York, NY
  • Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 · New York, NY

North Carolina · 2

  • UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 · Chapel Hill, NC
  • Cross Creek Medical Clinic-Site Number: 8400057 · Fayetteville, NC

Ohio · 4

  • Medical Associates Research Group-Site Number: 8400063 · Columbus, OH
  • Ohio Gastroenterology Group Inc.-Site Number: 8400006 · Columbus, OH
  • OSU Wexner Medical Center-Site Number: 8400077 · Columbus, OH
  • North Shore Gastroenterology Research-Site Number: 8400130 · Westlake, OH

Pennsylvania · 2

  • University of Pennsylvania School of Medicine-Site Number: 8400072 · Philadelphia, PA
  • The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 · Pittsburgh, PA

Rhode Island · 1

  • University Gastroenterology - GI Alliance-Site Number: 8400103 · Providence, RI

Texas · 5

  • GI Alliance - Lubbock-Site Number: 8400092 · Lubbock, TX
  • SMS Clinical Research-Site Number: 8400035 · Mesquite, TX
  • Gastroenterology Research of San Antonio LLC-Site Number: 8400054 · San Antonio, TX
  • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101 · Southlake, TX
  • Tyler Research Institute LLC-Site Number: 8400095 · Tyler, TX

Washington · 1

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

Wyoming · 1

  • Gastroenterology Associates of Western Michigan-Site Number: 8400060 · Wyoming, WY

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.