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NCT07184944RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
751 (estimated)
First submitted
15 Sept 2025
Start date
22 Jan 2026
Primary completion date
13 Aug 2029
Lead sponsor
Sanofi
NCT number
NCT07184944
EudraCT number
2025-521037-86

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 751
  • From 22 Jan 2026 to the primary completion date, 13 Aug 2029
  • 109 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (109)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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ViennaAustriaRecruiting
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SalzburgAustraliaRecruiting
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South BrisbaneAustraliaRecruiting
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ViennaAustraliaRecruiting
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YvoirBelgiumRecruiting
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Gorna OryahovitsaBulgariaRecruiting
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RousseBulgariaRecruiting
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SofiaBulgariaRecruiting
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
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São José do Rio PretoBrazilRecruiting
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EdmontonCanadaRecruiting
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HamiltonCanadaRecruiting
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LondonCanadaRecruiting
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New WestminsterCanadaRecruiting
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TorontoCanadaRecruiting
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BaselSwitzerlandRecruiting
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BernSwitzerlandRecruiting
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Viña del MarChileRecruiting
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GuangzhouChinaRecruiting
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HuizhouChinaRecruiting
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ShanghaiChinaRecruiting
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WuxiChinaRecruiting
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Hradec KrálovéCzechiaRecruiting
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PragueCzechiaRecruiting
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KielGermanyRecruiting
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LeipzigGermanyRecruiting
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UlmGermanyRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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JerusalemIsraelRecruiting
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Tel AvivIsraelRecruiting
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RozzanoItalyRecruiting
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TurinItalyRecruiting
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KamakuraJapanRecruiting
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NishinomiyaJapanRecruiting
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TsuJapanRecruiting
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BusanSouth KoreaRecruiting
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GwangjuSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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KaunasLithuaniaRecruiting
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ChisinauMoldovaRecruiting
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ChisinauMoldovaRecruiting
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ChisinauMoldovaRecruiting
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TilburgNetherlandsRecruiting
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Lower HuttNew ZealandRecruiting
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BydgoszczPolandRecruiting
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ElblagPolandRecruiting
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KatowicePolandRecruiting
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KłodzkoPolandRecruiting
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LublinPolandRecruiting
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RzeszówPolandRecruiting
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StaszówPolandRecruiting
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SzczecinPolandRecruiting
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TorunPolandRecruiting
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WadowicePolandRecruiting
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WarsawPolandRecruiting
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WroclawPolandRecruiting
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WroclawPolandRecruiting
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BelgradeSerbiaRecruiting
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BratislavaSlovakiaRecruiting
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Changhua CountyTaiwanRecruiting
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KyivUkraineRecruiting
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KyivUkraineRecruiting
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LvivUkraineRecruiting
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LvivUkraineRecruiting
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UzhhorodUkraineRecruiting
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VinnytsiaUkraineRecruiting
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VinnytsiaUkraineRecruiting
GI Alliance - Baton Rouge-Site Number: 8400129
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Baton RougeUnited StatesRecruiting
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
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Chapel HillUnited StatesRecruiting
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
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Colorado SpringsUnited StatesRecruiting
OSU Wexner Medical Center-Site Number: 8400077
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ColumbusUnited StatesRecruiting
Medical Associates Research Group-Site Number: 8400063
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ColumbusUnited StatesRecruiting
Ohio Gastroenterology Group Inc.-Site Number: 8400006
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ColumbusUnited StatesRecruiting
Cross Creek Medical Clinic-Site Number: 8400057
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FayettevilleUnited StatesRecruiting
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
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GurneeUnited StatesRecruiting
Clinical Research of Osceola-Site Number: 8400013
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KissimmeeUnited StatesRecruiting
BVL Clinical Research-Site Number: 8400005
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LibertyUnited StatesRecruiting
GI Alliance - Lubbock-Site Number: 8400092
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LubbockUnited StatesRecruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
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MandevilleUnited StatesRecruiting
MedTraits NY-Site Number: 8400045
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MaspethUnited StatesRecruiting
SMS Clinical Research-Site Number: 8400035
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MesquiteUnited StatesRecruiting
GI Alliance - Metairie-Site Number: 8400124
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MetairieUnited StatesRecruiting
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
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MiamiUnited StatesRecruiting
Columbus Clinical Services LLc-Site Number: 8400038
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MiamiUnited StatesRecruiting
Delta Research Partners-Site Number: 8400087
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MonroeUnited StatesRecruiting
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
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New AlbanyUnited StatesRecruiting
New York Gastroenterology Associates-Site Number: 8400009
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New YorkUnited StatesRecruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
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New YorkUnited StatesRecruiting
NYU Langone Health-Site Number: 8400091
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New YorkUnited StatesRecruiting
Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
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OrlandoUnited StatesRecruiting
University of Pennsylvania School of Medicine-Site Number: 8400072
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PhiladelphiaUnited StatesRecruiting
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
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PittsburghUnited StatesRecruiting
University Gastroenterology - GI Alliance-Site Number: 8400103
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ProvidenceUnited StatesRecruiting
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
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San AntonioUnited StatesRecruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
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SouthlakeUnited StatesRecruiting
Gateway Gastroenterology-Site Number: 8400097
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St LouisUnited StatesRecruiting
NMC Research LLC-Site Number: 8400033
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TampaUnited StatesRecruiting
Tyler Research Institute, LLC-Site Number: 8400095
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TylerUnited StatesRecruiting
The Vancouver Clinic Inc. P.S.-Site Number: 8400090
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VancouverUnited StatesRecruiting
North Shore Gastroenterology Research-Site Number: 8400130
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WestlakeUnited StatesRecruiting
Gastroenterology Associates of Western Michigan-Site Number: 8400060
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WyomingUnited StatesRecruiting
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Cape TownSouth AfricaRecruiting
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DurbanSouth AfricaRecruiting
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Kempton ParkSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.