A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04397263
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.

Study Details

The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.

Key Dates

Start date
Jun 10, 2020
Status verified
Feb 2026
Primary completion
Feb 29, 2024
Completion
Sep 12, 2025

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab
    Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From baseline (Week 0) up to Week 48 ]

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