NCT04397263

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

A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Crohns Disease

Interventions

Type	Name	Description
DRUG	Guselkumab	Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.

Timeline

• Start date: 2020-06-10
• Primary completion: 2024-02-29
• Completion: 2025-09-12
• First posted: 2020-05-21
• Last updated: 2026-02-25
• Results posted: 2025-05-20

Locations

25 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study