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
- Crohn Disease
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Enrolment target
- 78
- Started
- 30 December 2025
- Main results due
- 15 September 2027
- Study sites
- 5
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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 * Is currently enrolled in an interventional clinical study * Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome * Have a current or be suspected to have an abscess
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(5)
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Recruiting
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, China
Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Recruiting
Ruijin Hospital
Shanghai, China
Recruiting
Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07310095. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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