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NCT01959282 · ClinicalTrials.gov registry record · Phase 2
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 219
- Enrollment target
NCT01959282: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT01959282 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 219 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959282, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 219 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).
Primary Outcome
The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Interventions
- DRUG Placebo
- DRUG JNJ-54781532 25 mg once daily
- DRUG JNJ-54781532 75 mg once daily
- DRUG JNJ-54781532 150 mg once daily
- DRUG JNJ-54781532 75 mg twice daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2013-11-15 |
| Est. Completion | 2015-12-05 |
| Phase | Phase 2 |
What the finished NCT01959282 record still lists
NCT01959282 is an interventional study that assigns participants to a tested intervention. The registered 219 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 (65% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01959282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01959282 about?
NCT01959282 is a clinical study titled "A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis". The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).
What is the current status of trial NCT01959282?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 219 participants. The study started on 2013-11-15. Estimated completion is 2015-12-05.
What interventions are being tested in trial NCT01959282?
The interventions under investigation include: Placebo (DRUG), JNJ-54781532 25 mg once daily (DRUG), JNJ-54781532 75 mg once daily (DRUG), JNJ-54781532 150 mg once daily (DRUG), JNJ-54781532 75 mg twice daily (DRUG).
Who is sponsoring clinical trial NCT01959282?
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 NCT01959282's enrollment target sits among peer trials
219 283rd of 2000 higher than 1,717 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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