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NCT02877134 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2 study of Crohn Disease, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 388
- Enrollment target
- 20
- Study locations
NCT02877134: Completed Phase 2 study of Crohn Disease, sponsored by Janssen Research & Development.
NCT02877134 is a Phase 2 study of Crohn Disease that has completed, run by Janssen Research & Development. The registered enrollment target is 388 participants, above the 200-participant average among 71 other Crohn Disease trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02877134, a Phase 2 study of Crohn Disease, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 388 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
Primary Outcome
The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the partici
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ustekinumab
- DRUG JNJ-64304500
Study Locations (20)
Florida
- - Coral Gables
- - Kissimmee
- - Miami
- - Miramar
- - Orlando
- - Winter Park
New York
- - Brooklyn
- - Great Neck
- - New York
- - Rochester
Louisiana
- - Houma
- - Lake Charles
- - Shreveport
Illinois
- - Chicago
- - Evanston
Colorado
- - Lone Tree
Georgia
- - Marietta
Indiana
- - Indianapolis
Maryland
- - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2016-08-25 |
| Est. Completion | 2022-01-24 |
| Phase | Phase 2 |
What the finished NCT02877134 record still lists
NCT02877134 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, above the 200-participant average among 71 other Crohn Disease trials with a reported enrollment target (94% higher).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02877134 names 20 study sites across 9 states, led by Florida, New York, Louisiana.
Frequently Asked Questions
What is clinical trial NCT02877134 about?
NCT02877134 is a clinical study titled "Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease". The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
What is the current status of trial NCT02877134?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 388 participants. The study started on 2016-08-25. Estimated completion is 2022-01-24.
What conditions does trial NCT02877134 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT02877134?
The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG), JNJ-64304500 (DRUG).
Who is sponsoring clinical trial NCT02877134?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02877134 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02877134's enrollment target sits among peer trials
388 8th of 71 higher than 64 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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