Clinical trial NCT02034344: A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
Official title: Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Healthy
Keywords: Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Healthy
Active Cutaneous Lupus Erythematosus
Longitudinal Study
Biomarkers
Subacute Cutaneous Lupus Erythematosus
Skin Biopsy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The concentration of individual serum biomarkers
timeFrame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Secondary outcomes:
measure: The concentration of individual urine biomarkers
timeFrame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
measure: The concentration of individual skin biomarkers
timeFrame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Neptune
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Berlin
country: Germany
city: Kiel
country: Germany
city: Chihuahua
country: Mexico
city: Jalisco
country: Mexico
city: Mexico City
country: Mexico
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Wroclaw
country: Poland
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: