Guselkumab for Chinese adults with Crohn's disease who stopped responding to ustekinumab
Tests guselkumab in Chinese adults whose Crohn's disease no longer responds to ustekinumab.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Key facts
- Where
- Guangzhou, Hangzhou, Hefei, and Shanghai, ChinaSee the 5 sites
- Phase
- Phase 4
Where in China
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
- Ruijin hospitalShanghai, ChinaTaking 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
- Xian-Janssen Pharmaceutical Ltd.
- Trial code
- NCT07310095
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.Read full original descriptionShow less
Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
Inclusion: Has a confirmed diagnosis of Crohn's disease (CD); Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220; Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks; Initially responded to UST induction therapy and then lose response to UST; During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic.
Exclusion: Received UST dose optimization or multiple intravenous therapy in maintenance phase; Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months; Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome; Is currently enrolled in an interventional clinical study; Have a current or be suspected to have an abscess.