A Non-drug Study Profiling Cutaneous Lupus

Completed

• Conditions: Lupus Erythematosus, Discoid; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic
• Interventions: Procedure: No intervention, skin biopsy; Procedure: No intervention, blood collection; Procedure: No intervention, urine collection

• Registration Number: NCT01923415
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.

Detailed Description

This is a Phase 0, multiple-center observational study of biomarkers and clinical parameters in patients with lupus, including discoid lupus erythematosus (DLE), subacute cutaneous LE (SCLE) and active systemic lupus erythematosus (SLE). There is no study-related therapeutic intervention and this protocol will not restrict or introduce any medical interventions including medications. Study participants will undergo procedures that include collection of urine, blood samples, and skin biopsy. At least 30 participants (≥10 DLE, ≥10 SCLE, and ≥10 SLE) will be enrolled in this study. All participants will continue to be managed by their personal physicians per their standard of care. The data obtained in this study will help in the evaluation of new therapeutics for lupus and may facilitate lupus drug discovery. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. There will be a single sample collection time point for each patient. The safety assessments will include laboratory measurements (serum chemistry and hematology), monitoring of adverse events (AEs) related to study procedures, and physical examination.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-15
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• have active DLE or active SCLE confirmed by histological analysis
• have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of >6 and current or historical positive ANA or anti-dsDNA
• have an active skin lesion that can be biopsied
• if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening.

Exclusion Criteria

• have an active skin disease other than CLE

  • have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence)
  • have used a topical corticosteroid on active lesion
  • have donated blood (volume >=500 mL) within 56 days prior to screening
  • has been treated with drugs that are associated with CLE induction within 2 months prior to the screening
  • have been treated with >10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: SLE	No intervention, skin biopsy	\>=10 participants with systemic lupus erythematosus (SLE)
Group 1: SLE	No intervention, blood collection	\>=10 participants with systemic lupus erythematosus (SLE)
Group 1: SLE	No intervention, urine collection	\>=10 participants with systemic lupus erythematosus (SLE)
Group 2: DLE	No intervention, skin biopsy	\>=10 participants with discoid lupus erythematosus (DLE)
Group 2: DLE	No intervention, blood collection	\>=10 participants with discoid lupus erythematosus (DLE)
Group 2: DLE	No intervention, urine collection	\>=10 participants with discoid lupus erythematosus (DLE)
Group 3: SCLE	No intervention, skin biopsy	\>=10 participants with subacute cutaneous lupus erythematosus (SCLE)
Group 3: SCLE	No intervention, blood collection	\>=10 participants with subacute cutaneous lupus erythematosus (SCLE)
Group 3: SCLE	No intervention, urine collection	\>=10 participants with subacute cutaneous lupus erythematosus (SCLE)

Primary Outcome Measures

Name	Time	Method
Assessment of biomarkers in skin biopsies	Day 1	Investigation of pathways which may be dysregulated in cutaneous lupus lesions.

Secondary Outcome Measures

Name	Time	Method
Urine Biomarkers analysis	Day 1	The presence of potential biomarkers of disease activity will be explored in urine.
Blood Biomarkers analysis	Day 1	The presence of potential biomarkers of disease activity will be explored in blood.