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NCT03662542 · ClinicalTrials.gov registry record · Phase 2
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT03662542: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03662542 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 214 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03662542, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
Primary Outcome
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A sc
Interventions
- DRUG Placebo
- DRUG Guselkumab Dose 1
- DRUG Guselkumab Dose 2
- DRUG Golimumab Dose 1
- DRUG Golimumab Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2021-11-15 |
| Phase | Phase 2 |
What the finished NCT03662542 record still lists
NCT03662542 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03662542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03662542 about?
NCT03662542 is a clinical study titled "A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
What is the current status of trial NCT03662542?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2018-11-20. Estimated completion is 2021-11-15.
What interventions are being tested in trial NCT03662542?
The interventions under investigation include: Placebo (DRUG), Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Golimumab Dose 1 (DRUG), Golimumab Dose 2 (DRUG).
Who is sponsoring clinical trial NCT03662542?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03662542's enrollment target sits among peer trials
214 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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