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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy

Intervention / Treatment
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* Procedure: Skin biopsy
* Procedure: Blood collection
* Procedure: Urine collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Healthy participants<br>20 healthy participants will be enrolled. | Procedure: Skin biopsy<br>* 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.<br>Procedure: Blood collection<br>* 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.<br>Procedure: Urine collection<br>* Urine will be collected from all participants.<br>|
| Group 2: DLE/SCLE without SLE<br>30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled. | Procedure: Skin biopsy<br>* 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.<br>Procedure: Blood collection<br>* 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.<br>Procedure: Urine collection<br>* Urine will be collected from all participants.<br>|
| Group 3: DLE/SCLE with SLE<br>30 participants with DLE/SCLE with SLE will be enrolled. | Procedure: Skin biopsy<br>* 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.<br>Procedure: Blood collection<br>* 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.<br>Procedure: Urine collection<br>* Urine will be collected from all participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of individual serum biomarkers | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Active Cutaneous Lupus Erythematosus, Longitudinal Study, Biomarkers, Subacute Cutaneous Lupus Erythematosus, Skin Biopsy