NCT07310095 A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
| NCT ID | NCT07310095 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Xian-Janssen Pharmaceutical Ltd. |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2027-09-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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 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 requiri