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NCT05197049 · ClinicalTrials.gov registry record · Phase 3
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study of Crohn Disease, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT05197049 is a Phase 3 study of Crohn Disease that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 350 participants, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT05197049, a Phase 3 study of Crohn Disease, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Guselkumab Dose 1
- DRUG Guselkumab Dose 2
- DRUG Guselkumab Dose 3
Study Locations (20)
California
- Om Research LLC - Lancaster
- United Gastroenterologists - Los Alamitos
- Paul Wallace MD - Los Angeles
- Clinnova Research - Orange
- Digestive System Healthcare - Pasadena
- Northshore Gastroenterology Research, LLC - San Diego
- Clinical Applications Laboratories, Inc - San Diego
- Santa Maria Gastroenterology - Santa Maria
- Clinical Research of California - Walnut Creek
Florida
- Gastroenterology Associates of SW Florida - Clearwater
- Pioneer Research Solutions Inc. - Coconut Creek
- Omega Research Consultants - DeBary
- Harmony Medical Research Institute, Inc. - Hialeah
Arizona
- Advanced Gastro P.C - Chandler
- Reliance Research - Scottsdale
Arkansas
- Moore Clinical Trials, LLC - Little Rock
- Central Arkansas Veterans Healthcare System - Little Rock
Alabama
- Digestive Health Specialists of the Southeast - Dothan
Colorado
- Amel Med LLC Research - Grand Junction
Connecticut
- Western Connecticut Health Network/Danbury Hospital - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2022-01-19 |
| Est. Completion | 2028-10-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05197049
The ClinicalTrials.gov registry entry for NCT05197049 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 71 other Crohn Disease trials with a reported enrollment target (74% higher). 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 Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05197049 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05197049 about?
NCT05197049 is a clinical study titled "A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
What is the current status of trial NCT05197049?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2022-01-19. Estimated completion is 2028-10-30.
What conditions does trial NCT05197049 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT05197049?
The interventions under investigation include: Placebo (DRUG), Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Guselkumab Dose 3 (DRUG).
Who is sponsoring clinical trial NCT05197049?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05197049 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.