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NCT03466411 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Crohn's Disease, sponsored by Janssen Research & Development.

Active
Registry status
Phase 2
Development phase
1,409
Enrollment target
20
Study locations

NCT03466411 is a Phase 2 study of Crohn's Disease that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 1,409 participants, below the 2,381-participant average among 105 other Crohn's Disease trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT03466411, a Phase 2 study of Crohn's Disease, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
1,409 participants
Enrollment target
20
Study locations

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

Crohn's Disease

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

593 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, categorized as Phase 2. The registered enrollment target is 1,409 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,381-participant average among 105 other Crohn's Disease trials with a reported enrollment target (41% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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.

NCT03466411 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Alabama.

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.

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).

Who is sponsoring clinical trial NCT03466411?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.