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
- Diseases
- Crohn's disease
- 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
Sites (109)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| - Coordinator of this site? Confirm its status | Salzburg | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Vienna | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Gorna Oryahovitsa | Bulgaria | Recruiting |
| - Coordinator of this site? Confirm its status | Rousse | Bulgaria | Recruiting |
| - Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006 Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | New Westminster | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| - Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| - Coordinator of this site? Confirm its status | Viña del Mar | Chile | Recruiting |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Huizhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| - Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| - Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| - Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Kamakura | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Nishinomiya | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Tsu | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| - Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| - Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| - Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| - Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| - Coordinator of this site? Confirm its status | Lower Hutt | New Zealand | Recruiting |
| - Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Elblag | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Kłodzko | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Staszów | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Wadowice | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| - Coordinator of this site? Confirm its status | Changhua County | Taiwan | Recruiting |
| - Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| - Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| - Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
| - Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
| - Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Recruiting |
| - Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| - Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| GI Alliance - Baton Rouge-Site Number: 8400129 Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| OSU Wexner Medical Center-Site Number: 8400077 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Medical Associates Research Group-Site Number: 8400063 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Ohio Gastroenterology Group Inc.-Site Number: 8400006 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Cross Creek Medical Clinic-Site Number: 8400057 Coordinator of this site? Confirm its status | Fayetteville | United States | Recruiting |
| Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049 Coordinator of this site? Confirm its status | Gurnee | United States | Recruiting |
| Clinical Research of Osceola-Site Number: 8400013 Coordinator of this site? Confirm its status | Kissimmee | United States | Recruiting |
| BVL Clinical Research-Site Number: 8400005 Coordinator of this site? Confirm its status | Liberty | United States | Recruiting |
| GI Alliance - Lubbock-Site Number: 8400092 Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 Coordinator of this site? Confirm its status | Mandeville | United States | Recruiting |
| MedTraits NY-Site Number: 8400045 Coordinator of this site? Confirm its status | Maspeth | United States | Recruiting |
| SMS Clinical Research-Site Number: 8400035 Coordinator of this site? Confirm its status | Mesquite | United States | Recruiting |
| GI Alliance - Metairie-Site Number: 8400124 Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| Bioresearch Partner-Kendale Lakes-Site Number: 8400053 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Columbus Clinical Services LLc-Site Number: 8400038 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Delta Research Partners-Site Number: 8400087 Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 Coordinator of this site? Confirm its status | New Albany | United States | Recruiting |
| New York Gastroenterology Associates-Site Number: 8400009 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Langone Health-Site Number: 8400091 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084 Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| University of Pennsylvania School of Medicine-Site Number: 8400072 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| University Gastroenterology - GI Alliance-Site Number: 8400103 Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| Gastroenterology Research of San Antonio LLC-Site Number: 8400054 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101 Coordinator of this site? Confirm its status | Southlake | United States | Recruiting |
| Gateway Gastroenterology-Site Number: 8400097 Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| NMC Research LLC-Site Number: 8400033 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Tyler Research Institute, LLC-Site Number: 8400095 Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| The Vancouver Clinic Inc. P.S.-Site Number: 8400090 Coordinator of this site? Confirm its status | Vancouver | United States | Recruiting |
| North Shore Gastroenterology Research-Site Number: 8400130 Coordinator of this site? Confirm its status | Westlake | United States | Recruiting |
| Gastroenterology Associates of Western Michigan-Site Number: 8400060 Coordinator of this site? Confirm its status | Wyoming | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Kempton Park | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.