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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT03466411

Run by

Janssen Research & Development, LLC

People needed

1409

Starts

2018-04-13

Expected to finish

2028-01-28

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
• Have screening laboratory test results within the protocol specified parameters
• A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

You may not qualify if…

• Current diagnosis of ulcerative colitis or indeterminate colitis
• Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
• Unstable doses of concomitant Crohn's disease therapy
• Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
• Any medical contraindications preventing study participation

Where it is running

• Internal Medicine Center — Mobile, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• Advanced Research Center Inc — Anaheim, California, United States
• Paul Wallace MD — Beverly Hills, California, United States
• University Of California San Diego — La Jolla, California, United States
• Om Research LLC — Lancaster, California, United States
• Allameh Medical Corp — Mission Viejo, California, United States
• United Gastroenterologists — Murrieta, California, United States
• Clinnova Research — Orange, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Clinical Applications Laboratories, Inc — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Pioneer Research Solutions Inc. — Coconut Creek, Florida, United States
• InvesClinic, LLC — Fort Lauderdale, Florida, United States
• Harmony Medical Research Institute, Inc. — Hialeah, Florida, United States
• Elite Research Network - Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• SIH Research — Kissimmee, Florida, United States
• Auzmer Research — Lakeland, Florida, United States
• Florida Research Center Inc. — Lakewood Rch, Florida, United States
• Homestead Associates in Research Inc — Miami, Florida, United States
• Community Research Foundation, Inc. — Miami, Florida, United States
• Sanchez Clinical Research, Inc — Miami, Florida, United States
• Visionary Investigators Network — Miami, Florida, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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