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

NCT04397263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-02-25

Study results available
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Summary

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

Conditions

  • Crohns Disease

Interventions

DRUG

Guselkumab

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

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2024-02-29
Completion
2025-09-12
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04397263 on ClinicalTrials.gov