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NCT02609789 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus
A Phase 1 study of Healthy and Systemic Lupus Erythematosus, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 16
- Study locations
NCT02609789: Completed Phase 1 study of Healthy and Systemic Lupus Erythematosus, sponsored by Janssen Research & Development.
NCT02609789 is a Phase 1 study of Healthy and Systemic Lupus Erythematosus that has completed, run by Janssen Research & Development. The registered enrollment target is 72 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 16 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02609789, a Phase 1 study of Healthy and Systemic Lupus Erythematosus, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).
Primary Outcome
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JNJ-55920839
Study Locations (16)
Other
- - Leuven
- - Merksem
- - Chisinau
- - Otwock
- - Szczecin
- - Bucharest
- - Timișoara
- - Barcelona
- - Madrid
- - Santiago de Compostela
- - Seville
- - Kaohsiung City
- - Taichung
Alabama
- - Birmingham
Minnesota
- - Rochester
North Carolina
- - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-12 |
| Est. Completion | 2018-09 |
| Phase | Phase 1 |
What the finished NCT02609789 record still lists
NCT02609789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02609789 lists 16 locations in 4 states (Other, Alabama, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02609789 about?
NCT02609789 is a clinical study titled "A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus". The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate...
What is the current status of trial NCT02609789?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2015-12. Estimated completion is 2018-09.
What conditions does trial NCT02609789 study?
This clinical trial studies the following conditions: Healthy, Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT02609789?
The interventions under investigation include: Placebo (DRUG), JNJ-55920839 (DRUG).
Who is sponsoring clinical trial NCT02609789?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02609789 being conducted?
This trial has 16 study locations across Alabama, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT02609789's enrollment target sits among peer trials
72 314th of 1090 higher than 770 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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