A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

December 15, 2016 updated by: Janssen Research & Development, LLC

Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 0 multi-center and longitudinal study of biomarkers and clinical parameters in patients with lupus erythematosus (LE). Approximately 80 participants (20 healthy participants and 60 patients with LE) will be enrolled. This will include 30 with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE), and 30 with DLE/SCLE with SLE. All patients with LE will continue to be managed by their personal physicians per their standard-of-care. Study participants will undergo interventional procedures that include collection of urine, blood samples and skin biopsy. There will be a single sample collection timepoint for healthy participants and two sample collection timepoints for LE patients, separated by approximately 12 weeks. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. The data obtained in this study will be used in the evaluation of new therapies for lupus and may help in developing new treatments. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examinations. The total duration of study participation will be approximately 11 days for healthy participants and 95 days for patients with LE.

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
      • Kiel, Germany
  • Mexico
      • Chihuahua, Mexico
      • Jalisco, Mexico
      • Mexico City, Mexico
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Wroclaw, Poland
  • Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
  • United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
  • United States
    • California
      • La Jolla, California, United States
    • Illinois
      • Chicago, Illinois, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • New Jersey
      • Neptune, New Jersey, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy participants and participants with Discoid Lupus Erythematosus (DLE)/Subacute Cutaneous Lupus Erythematosus (SCLE) without Systemic Lupus Erythematosus (SLE) and DLE/SCLE with SLE will be observed.

Description

Inclusion Criteria:

  • Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)
  • Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)
  • Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)
  • An active skin lesion that can be biopsied (for participants with lupus erythematosus)

Exclusion Criteria:

  • Known or thought to have a diagnosis of drug-induced lupus
  • An active skin disease that is not a manifestation of lupus erythematosus
  • Has an acute cutaneous lupus erythematosus rash only
  • If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1
  • Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1
  • Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Healthy participants
20 healthy participants will be enrolled.
Procedure: Skin biopsy
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Procedure: Blood collection
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Procedure: Urine collection
Urine will be collected from all participants.
Group 2: DLE/SCLE without SLE
30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.
Procedure: Skin biopsy
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Procedure: Blood collection
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Procedure: Urine collection
Urine will be collected from all participants.
Group 3: DLE/SCLE with SLE
30 participants with DLE/SCLE with SLE will be enrolled.
Procedure: Skin biopsy
Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
Procedure: Blood collection
Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
Procedure: Urine collection
Urine will be collected from all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The concentration of individual serum biomarkers
Time Frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Investigation of pathways which may be dysregulated in cutaneous lupus lesions
Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The concentration of individual urine biomarkers
Time Frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
The presence of potential biomarkers of disease activity will be explored in urine.
Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
The concentration of individual skin biomarkers
Time Frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
The presence of potential biomarkers of disease activity will be explored in blood.
Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR102355
  • NOCOMPOUNDLUP0001 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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