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

Completed

• Conditions: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic; Healthy
• Interventions: Procedure: Skin biopsy; Procedure: Blood collection; Procedure: Urine collection

• Registration Number: NCT02034344
• Lead Sponsor: Janssen Research & Development, LLC

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Healthy participants	Blood collection	20 healthy participants will be enrolled.
Group 1: Healthy participants	Urine collection	20 healthy participants will be enrolled.
Group 2: DLE/SCLE without SLE	Skin biopsy	30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.
Group 3: DLE/SCLE with SLE	Urine collection	30 participants with DLE/SCLE with SLE will be enrolled.
Group 1: Healthy participants	Skin biopsy	20 healthy participants will be enrolled.
Group 3: DLE/SCLE with SLE	Skin biopsy	30 participants with DLE/SCLE with SLE will be enrolled.
Group 3: DLE/SCLE with SLE	Blood collection	30 participants with DLE/SCLE with SLE will be enrolled.
Group 2: DLE/SCLE without SLE	Blood collection	30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.
Group 2: DLE/SCLE without SLE	Urine collection	30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.

Primary Outcome Measures

Name	Time	Method
The concentration of individual serum biomarkers	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

Secondary Outcome Measures

Name	Time	Method
The concentration of individual skin biomarkers	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.
The concentration of individual urine biomarkers	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.