NCT07310095RecruitingPhase 4
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 30 Dec 2025
- Primary completion date
- 15 Sept 2027
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Diseases
- Crohn's disease
- NCT number
- NCT07310095
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 78
- From 30 Dec 2025 to the primary completion date, 15 Sept 2027
- 5 sites in 1 country
- 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.
Prior treatment
- 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
Other illness
- Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
Other
- Is currently enrolled in an interventional clinical study
- Have a current or be suspected to have an abscess
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.