A Non-drug Study Profiling Cutaneous Lupus

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01923415

Collaborator

(none)

Enrollment

Locations

Duration (Months)

9.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid	Procedure: No intervention, skin biopsy Procedure: No intervention, blood collection Procedure: No intervention, urine collection

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 Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Group 1: SLE >=10 participants with systemic lupus erythematosus (SLE)	Procedure: No intervention, skin biopsy All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies). Procedure: No intervention, blood collection Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately. Procedure: No intervention, urine collection Urine will be collected from all participants.
Group 2: DLE >=10 participants with discoid lupus erythematosus (DLE)	Procedure: No intervention, skin biopsy All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies). Procedure: No intervention, blood collection Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately. Procedure: No intervention, urine collection Urine will be collected from all participants.
Group 3: SCLE >=10 participants with subacute cutaneous lupus erythematosus (SCLE)	Procedure: No intervention, skin biopsy All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies). Procedure: No intervention, blood collection Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately. Procedure: No intervention, urine collection Urine will be collected from all participants.

Arm

Intervention/Treatment

Group 1: SLE

>=10 participants with systemic lupus erythematosus (SLE)

Procedure: No intervention, skin biopsy

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

Procedure: No intervention, blood collection

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

Procedure: No intervention, urine collection

Urine will be collected from all participants.

Group 2: DLE

>=10 participants with discoid lupus erythematosus (DLE)

Procedure: No intervention, skin biopsy

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

Procedure: No intervention, blood collection

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

Procedure: No intervention, urine collection

Urine will be collected from all participants.

Group 3: SCLE

>=10 participants with subacute cutaneous lupus erythematosus (SCLE)

Procedure: No intervention, skin biopsy

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

Procedure: No intervention, blood collection

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

Procedure: No intervention, urine collection

Urine will be collected from all participants.

Outcome Measures

Primary Outcome Measures

Assessment of biomarkers in skin biopsies [Day 1]
Investigation of pathways which may be dysregulated in cutaneous lupus lesions.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.