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NCT04033445 · ClinicalTrials.gov registry record · Phase 2
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 1,064
- Enrollment target
- 20
- Study locations
NCT04033445 is a Phase 2 study of Ulcerative Colitis that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 1,064 participants, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT04033445, a Phase 2 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,064 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 moderately to severely active ulcerative colitis (UC).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Guselkumab
Study Locations (20)
Florida
- Florida Research Network, LLC - Gainesville
- University of Florida Health Jacksonville - Gainesville
- Harmony Medical Research Institute, Inc. - Hialeah
- UF Health Jacksonville Gastroenterology Emerson - Jacksonville
- I.H.S. Health. LLC - Kissimmee
- Columbus Clinical Services LLC - Miami
- Vista Health Research, LLC - Miami
- Orlando Health - Orlando
- Care Access Research, Orlando - Orlando
- Synexus Clinical Research US Inc 2 - Pinellas Park
- Univ. of South Florida Med. Group - Tampa
Georgia
- Atlanta Gastroenterology Associates - Atlanta
- Morehouse School of Medicine - Atlanta
- The Emory Clinic - Atlanta
- Atlanta Gastroenterology Associates 1 - Atlanta
- Atlanta Center For Gastroenterology - Decatur
- Gastroenterolgy Associates of Central GA - Macon
California
- Om Research LLC - Lancaster
- UCLA - Los Angeles
Colorado
- Peak Gastroenterology Associates 1 - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,064 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2027-09-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04033445
The ClinicalTrials.gov registry entry for NCT04033445 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 1,064 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (48% 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 Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04033445 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT04033445 about?
NCT04033445 is a clinical study titled "A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
What is the current status of trial NCT04033445?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,064 participants. The study started on 2019-09-26. Estimated completion is 2027-09-29.
What conditions does trial NCT04033445 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT04033445?
The interventions under investigation include: Placebo (DRUG), Guselkumab (DRUG).
Who is sponsoring clinical trial NCT04033445?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04033445 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia. 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.