A Non-drug Study Profiling Cutaneous Lupus

Cross-Sectional Study in Subjects With Active Cutaneous Lupus Erythematosus

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

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland
• United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Texas
    • Dallas, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants have CLE (either DLE or SCLE) or SLE with cutaneous manifestations

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of biomarkers in skin biopsies	Investigation of pathways which may be dysregulated in cutaneous lupus lesions.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Biomarkers analysis	The presence of potential biomarkers of disease activity will be explored in urine.	Day 1
Blood Biomarkers analysis	The presence of potential biomarkers of disease activity will be explored in blood.	Day 1

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Study, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (ESTIMATE): August 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 11, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Skin Biopsy; Lupus Erythematosus, Systemic; Lesions; Lupus Erythematosus, Subacute, Cutaneous; Lupus Erythematosus, Discoid; Active Cutaneous Lupus Erythematosus; Systemic Cutaneous Lupus Erythematosus
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
• Other Study ID Numbers: CR101971; 2013-001531-46 (EUDRACT_NUMBER); NOCOMPOUNDLUN0001 (OTHER: Janssen Research & Development, LLC)