Tests duvakitug in adults with active Crohn's disease
Tests duvakitug against placebo in people with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Asahikawa, Bunkyō City, Chikushino-shi, Fukuoka, Hachiōji, Isehara, Isesaki, Kagoshima, Kamakura, Kashiwa, Kitakyushu, Kobe, Kōriyama, Kumamoto, Kurume, Maebashi, Minato, Mitaka, Nagakute, Nagoya, Nishinomiya, Okayama, Osaka, Saga, Sagamihara, Sakura, Sapporo, Sendai, Shimotsuga-gun, Shinjuku, Shiwa-gun, Shizuoka, Toyama, Toyohashi, Tsu, and Yokohama, JapanSee the 49 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT07184931, who can take part
Where in Japan
- AsahikawaAsahikawa, JapanTaking people
- Bunkyō CityBunkyō City, JapanTaking people
- Bunkyō CityBunkyō City, JapanTaking people
- Chikushino-shiChikushino-shi, JapanTaking people
- FukuokaFukuoka, JapanTaking people
- FukuokaFukuoka, JapanTaking people
- FukuokaFukuoka, JapanTaking people
- HachiōjiHachiōji, JapanTaking people
- IseharaIsehara, JapanTaking people
- IsesakiIsesaki, JapanTaking people
- KagoshimaKagoshima, JapanTaking people
- KamakuraKamakura, JapanTaking people
- KashiwaKashiwa, JapanTaking people
- KitakyushuKitakyushu, JapanTaking people
- KobeKobe, JapanTaking people
- KobeKobe, JapanTaking people
- KōriyamaKōriyama, JapanTaking people
- KumamotoKumamoto, JapanTaking people
- KurumeKurume, JapanTaking people
- MaebashiMaebashi, JapanTaking people
- MinatoMinato, JapanTaking people
- MitakaMitaka, JapanTaking people
- NagakuteNagakute, JapanTaking people
- NagoyaNagoya, JapanTaking people
- NagoyaNagoya, JapanTaking people
- NishinomiyaNishinomiya, JapanTaking people
- OkayamaOkayama, JapanTaking people
- OsakaOsaka, JapanTaking people
- OsakaOsaka, JapanTaking people
- OsakaOsaka, JapanTaking people
- SagaSaga, JapanTaking people
- SagaSaga, JapanTaking people
- SagamiharaSagamihara, JapanTaking people
- SakuraSakura, JapanTaking people
- SapporoSapporo, JapanTaking people
- SapporoSapporo, JapanTaking people
- SendaiSendai, JapanTaking people
- SendaiSendai, JapanTaking people
- SendaiSendai, JapanTaking people
- Shimotsuga-gunShimotsuga-gun, JapanTaking people
- ShinjukuShinjuku, JapanTaking people
- ShinjukuShinjuku, JapanTaking people
- Shiwa-gunShiwa-gun, JapanTaking people
- ShizuokaShizuoka, JapanTaking people
- ToyamaToyama, JapanTaking people
- ToyamaToyama, JapanTaking people
- ToyohashiToyohashi, JapanTaking people
- TsuTsu, JapanTaking people
- YokohamaYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07184931
- Record updated
- 21 October 2026
- Original description
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:Read full original descriptionShow less
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:
The study duration may be up to 35 weeks with:
* Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.
The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
Inclusion: Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development; Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline; Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs).
Exclusion: Prior or current high-grade gastrointestinal (GI) dysplasia; Participants on treatment with but not on stable doses of conventional therapy prior to baseline; Participants receiving prohibited medications or therapies; Participants with previous exposure to anti-TL1A investigational therapy; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial; Participants with Ulcerative Colitis (UC) or indeterminate colitis; Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum.