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COMPLETED 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

NCT02609789 · View on ClinicalTrials.gov ↗

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).

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

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02609789

The ClinicalTrials.gov registry entry for NCT02609789 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02609789 reports 16 study locations spanning 4 distinct geographic areas — top geographies include Other, Alabama, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02609789?

The interventions under investigation include: Placebo (DRUG), JNJ-55920839 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02609789?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial