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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 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.

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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).

Conditions Studied

Healthy Systemic Lupus Erythematosus

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

FieldValue
Enrollment Target 72 participants
Start Date 2015-12
Est. Completion 2018-09
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT02609789

The ClinicalTrials.gov registry entry for NCT02609789 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.