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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: Active Phase 2 study of Crohn's Disease, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicat
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
| Field | Value |
|---|---|
| Enrollment Target | 1,409 participants |
| Start Date | 2018-04-13 |
| Est. Completion | 2028-01-28 |
| Phase | Phase 2 |
What the registry record for NCT03466411 still lists
NCT03466411 is an interventional study that assigns participants to a tested intervention. Its 1,409 participants enrollment target places it among the larger protocols in the corpus, below the 2,381-participant average among 105 other Crohn's Disease trials with a reported enrollment target (41% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03466411's enrollment target sits among peer trials
1,409 5th of 105 higher than 101 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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