A Non-drug Study Profiling Cutaneous Lupus

N/ACompletedNCT01923415

Janssen Research & Development, LLC29 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid

Interventions

No intervention, skin biopsyPROCEDURE

All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).

No intervention, blood collectionPROCEDURE

Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.

No intervention, urine collectionPROCEDURE

Urine will be collected from all participants.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Indianapolis, Indiana, United States

Unnamed facility

Dallas, Texas, United States

Unnamed facility

Lodz, Poland

Outcomes

Primary Outcomes

Assessment of biomarkers in skin biopsies

Investigation of pathways which may be dysregulated in cutaneous lupus lesions.

Time frame: Day 1

Secondary Outcomes

Urine Biomarkers analysis

The presence of potential biomarkers of disease activity will be explored in urine.

Time frame: Day 1

Blood Biomarkers analysis

The presence of potential biomarkers of disease activity will be explored in blood.

Time frame: Day 1

Data from ClinicalTrials.gov

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