Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab
Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab
This study tests whether guselkumab can help Chinese patients with active Crohn's disease who initially responded to ustekinumab but later lost response.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xian-Janssen Pharmaceutical Ltd. Industry-sponsored |
| Drugs / interventions | ustekinumab, guselkumab |
| Locations | 5 sites (Guangzhou and 4 other locations) |
| Trial ID | NCT07310095 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with confirmed active Crohn's disease (CDAI ≥220 and required symptom thresholds) who received standard ustekinumab induction, initially responded, and then lost response are ideal candidates.
Not a fit: Patients who are still responding well to ustekinumab, who received nonstandard ustekinumab dosing, or who have exclusionary conditions are unlikely to benefit from switching in this study.
Why it matters
Potential benefit: If successful, guselkumab could provide an effective treatment option for patients with Crohn's disease who no longer respond to ustekinumab.
How similar studies have performed: Blocking IL-23 has shown benefit in Crohn's disease with other drugs (for example risankizumab), but guselkumab's effectiveness in this specific ustekinumab nonresponder population is less established.
Eligibility criteria
Show full inclusion / exclusion 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 and either mean daily stool frequency (SF) count \>= 4 or mean daily abdominal pain (AP) score \>=2 * Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \[mg\]/kilogram \[kg\] intravenous \[IV\] followed by 90 mg subcutaneous \[SC\] at week 8) as the instruction manual * 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: * Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual) * 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 this trial is running
Guangzhou and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.