A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
Condition: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid; Healthy
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
Study type: Observational

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.
    

Intervention name(s): Skin biopsy; Blood collection; Urine collection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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.; 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.; Urine will be collected from all participants.
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.
      
Keywords: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid; Healthy; Active Cutaneous Lupus Erythematosus; Longitudinal Study; Biomarkers; Subacute Cutaneous Lupus Erythematosus; Skin Biopsy