๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-30

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (NCT03466411)

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

๐Ÿ”ต Active, Not Recruiting Phase2 / Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Digestive Health Specialists of the Southeast โ€” Dothan, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (579 Sites)

Showing the first 25 of 579 sites.

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

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Crohn's Disease clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—