๐๏ธ Verified NIH Record โข 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
๐ต Active, Not Recruiting Phase2 / Phase3 ๐ Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) โ Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease โ Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. โ Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. โ Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients โ San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis โ Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.