A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Sponsor
Xian-Janssen Pharmaceutical Ltd.
Study ID
NCT07310095
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab (GUS) — DRUG
    Guselkumab will be administered intravenously or by subcutaneous injection.

Study Details

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.

Key Dates

Start date
Dec 30, 2025
Status verified
Jun 2026
Primary completion
Sep 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab Treatment
    Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Remission At Week 48 [ Time Frame: At Week 48 ]

Central Contacts

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