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ACTIVE NOT RECRUITING Phase 2

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

NCT03466411 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Guselkumab Dose 1
  • DRUG Guselkumab Dose 2
  • DRUG Guselkumab Dose 3
  • DRUG Guselkumab Dose 4
  • DRUG Guselkumab Dose 5

Study Locations (20)

California

  • Advanced Research Center Inc — Anaheim
  • Paul Wallace MD — Beverly Hills
  • University Of California San Diego — La Jolla
  • Om Research LLC — Lancaster
  • Allameh Medical Corp — Mission Viejo
  • United Gastroenterologists — Murrieta
  • Clinnova Research — Orange
  • Inland Empire Liver Foundation — Rialto
  • UC Davis Medical Center — Sacramento
  • Clinical Applications Laboratories, Inc — San Diego

Florida

  • Pioneer Research Solutions Inc. — Coconut Creek
  • InvesClinic, LLC — Fort Lauderdale
  • Harmony Medical Research Institute, Inc. — Hialeah
  • Elite Research Network - Nature Coast Clinical Research, LLC — Inverness
  • SIH Research — Kissimmee
  • Auzmer Research — Lakeland

Alabama

  • Digestive Health Specialists of the Southeast — Dothan
  • Internal Medicine Center — Mobile

Arizona

  • University of Arizona — Tucson

Colorado

  • Peak Gastroenterology Associates — Colorado Springs

Trial Details

FieldValue
Enrollment Target 1,409 participants
Start Date 2018-04-13
Est. Completion 2028-01-28
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03466411

The ClinicalTrials.gov registry entry for NCT03466411 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,409 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 5 interventions — of which Guselkumab Dose 1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03466411 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03466411 about?

NCT03466411 is a clinical study titled "A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease". 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.

What is the current status of trial NCT03466411?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,409 participants. The study started on 2018-04-13. Estimated completion is 2028-01-28.

What conditions does trial NCT03466411 study?

This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03466411?

The interventions under investigation include: Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Guselkumab Dose 3 (DRUG), Guselkumab Dose 4 (DRUG), Guselkumab Dose 5 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03466411?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03466411 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial