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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: Active Phase 2 study of Ulcerative Colitis, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with
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 |
What the registry record for NCT04033445 still lists
NCT04033445 is an interventional study that assigns participants to a tested intervention. Its 1,064 participants enrollment target places it among the larger protocols in the corpus, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (48% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
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Where NCT04033445's enrollment target sits among peer trials
1,064 8th of 122 higher than 115 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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