Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study enrolls Chinese participants with active Crohn's disease (CDAI ≥220 and qualifying stool frequency or abdominal pain scores) who received at least the standard ustekinumab induction and initially responded but subsequently lost response. Eligible participants will receive guselkumab and be followed for clinical response and safety outcomes using CDAI, symptom diaries, and routine labs. The trial is conducted at three tertiary university-affiliated hospitals in China and follows standard clinical visit schedules to track symptom change and adverse events. Results will clarify whether switching to guselkumab can recapture disease control in this specific patient group.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.