A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Summary

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

Conditions

• Crohn's Disease

Interventions

DRUG

Guselkumab Dose 1

Guselkumab will be administered by IV infusion.

DRUG

Guselkumab Dose 2

Guselkumab will be administered by SC injection.

DRUG

Guselkumab Dose 3

Guselkumab will be administered by IV infusion.

DRUG

Guselkumab Dose 4

Guselkumab will be administered by IV infusion.

DRUG

Guselkumab Dose 5

Guselkumab will be by SC injection.

DRUG

Guselkumab

Guselkumab will be administered by IV infusion and SC injection.

DRUG

Ustekinumab

Ustekinumab will be administered by IV infusion and SC injection.

DRUG

Placebo

Placebo will be administered as IV infusion.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-13

Primary Completion

2023-10-20

Completion

2028-01-28

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belarus
• Belgium
• Bosnia and Herzegovina
• Brazil
• Canada
• China
• Colombia
• Croatia
• Czechia
• France
• Georgia
• Germany
• Greece
• Hungary
• India
• Israel
• Italy
• Japan
• Jordan
• Latvia
• Lebanon
• Lithuania
• Malaysia
• Netherlands
• New Zealand
• North Macedonia
• Poland
• Portugal
• Puerto Rico
• Russia
• Saudi Arabia
• Serbia
• Slovakia
• South Korea
• Spain
• Taiwan
• Tunisia
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations