A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
- Crohn's Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Sanofi
- Enrolment target
- 751
- Started
- 22 January 2026
- Main results due
- 13 August 2029
- Study sites
- 90
- Registry updated
- 23 September 2026
Can you take part?
- Ages 16 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(90)
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado, United States
Recruiting
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, Florida, United States
Recruiting
Columbus Clinical Services LLc-Site Number: 8400038
Miami, Florida, United States
Recruiting
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida, United States
Recruiting
Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
Orlando, Florida, United States
Recruiting
NMC Research LLC-Site Number: 8400033
Tampa, Florida, United States
Recruiting
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
Gurnee, Illinois, United States
Recruiting
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
New Albany, Indiana, United States
Recruiting
GI Alliance - Baton Rouge-Site Number: 8400129
Baton Rouge, Louisiana, United States
Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
Mandeville, Louisiana, United States
Recruiting
GI Alliance - Metairie-Site Number: 8400124
Metairie, Louisiana, United States
Recruiting
Delta Research Partners-Site Number: 8400087
Monroe, Louisiana, United States
Recruiting
BVL Clinical Research-Site Number: 8400005
Liberty, Missouri, United States
Recruiting
Gateway Gastroenterology-Site Number: 8400097
St Louis, Missouri, United States
Recruiting
MedTraits NY-Site Number: 8400045
Maspeth, New York, United States
Recruiting
NYU Langone Health-Site Number: 8400091
New York, New York, United States
Recruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
New York, New York, United States
Recruiting
New York Gastroenterology Associates-Site Number: 8400009
New York, New York, United States
Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
Chapel Hill, North Carolina, United States
Recruiting
Cross Creek Medical Clinic-Site Number: 8400057
Fayetteville, North Carolina, United States
Recruiting
Ohio Gastroenterology Group Inc.-Site Number: 8400006
Columbus, Ohio, United States
Recruiting
Medical Associates Research Group-Site Number: 8400063
Columbus, Ohio, United States
Recruiting
OSU Wexner Medical Center-Site Number: 8400077
Columbus, Ohio, United States
Recruiting
North Shore Gastroenterology Research-Site Number: 8400130
Westlake, Ohio, United States
Recruiting
University of Pennsylvania School of Medicine-Site Number: 8400072
Philadelphia, Pennsylvania, United States
Recruiting
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
Pittsburgh, Pennsylvania, United States
Recruiting
University Gastroenterology - GI Alliance-Site Number: 8400103
Providence, Rhode Island, United States
Recruiting
GI Alliance - Lubbock-Site Number: 8400092
Lubbock, Texas, United States
Recruiting
SMS Clinical Research-Site Number: 8400035
Mesquite, Texas, United States
Recruiting
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
San Antonio, Texas, United States
Recruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
Southlake, Texas, United States
Recruiting
Tyler Research Institute LLC-Site Number: 8400095
Tyler, Texas, United States
Recruiting
The Vancouver Clinic Inc. P.S.-Site Number: 8400090
Vancouver, Washington, United States
Recruiting
Gastroenterology Associates of Western Michigan-Site Number: 8400060
Wyoming, Wyoming, United States
Recruiting
Investigational Site Number : 0360001
South Brisbane, Queensland, Australia
Recruiting
Investigational Site Number : 0400002
Salzburg, Australia
Recruiting
Investigational Site Number : 0400007
Vienna, Australia
Recruiting
Investigational Site Number : 0560003
Yvoir, Belgium
Recruiting
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
São José do Rio Preto, Brazil
Recruiting
Investigational Site Number : 1000007
Rousse, Bulgaria
Recruiting
Investigational Site Number : 1000001
Sofia, Bulgaria
Recruiting
Investigational Site Number : 1240009
Hamilton, Canada
Recruiting
Investigational Site Number : 1240013
London, Canada
Recruiting
Investigational Site Number : 1240006
New Westminster, Canada
Recruiting
Investigational Site Number : 1240003
Toronto, Canada
Recruiting
Investigational Site Number : 1560002
Guangzhou, China
Recruiting
Investigational Site Number : 1560026
Huizhou, China
Recruiting
Investigational Site Number : 1560020
Shanghai, China
Recruiting
Investigational Site Number : 1560018
Wuxi, China
Recruiting
Investigational Site Number: 2030011
Hradec Králové, Czechia
Recruiting
Investigational Site Number : 2030013
Prague, Czechia
Recruiting
Investigational Site Number : 2680006
Tbilisi, Georgia
Recruiting
Investigational Site Number : 2680008
Tbilisi, Georgia
Recruiting
Investigational Site Number : 2680003
Tbilisi, Georgia
Recruiting
Investigational Site Number : 2680005
Tbilisi, Georgia
Recruiting
Investigational Site Number : 2680002
Tbilisi, Georgia
Recruiting
Investigational Site Number : 2680004
Tbilisi, Georgia
Recruiting
Investigational Site Number : 2760005
Ulm, Baden-Wurttemberg, Germany
Recruiting
Investigational Site Number : 3760001
Jerusalem, Israel
Recruiting
Investigational Site Number : 3760002
Tel Aviv, Israel
Recruiting
Showing 60 of 90 sites — filter to narrow it down. 90 of the 90 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07184944. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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