A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

Healthy Clinical Trial

Official title:

Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034344
• Other study ID #: CR102355
• Secondary ID: NOCOMPOUNDLUP000
• Status: Completed
• Phase: Phase 0
• First received: December 10, 2013
• Last updated: December 15, 2016
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: December 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics CommissionUnited States: Food and Drug AdministrationUnited States: State Food and Drug AdministrationUSA: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)

• Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)

• Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)

• An active skin lesion that can be biopsied (for participants with lupus erythematosus)

Exclusion Criteria:

• Known or thought to have a diagnosis of drug-induced lupus

• An active skin disease that is not a manifestation of lupus erythematosus

• Has an acute cutaneous lupus erythematosus rash only

• If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1

• Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1

• Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Intervention

Procedure:
• Skin biopsy
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 collection
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 collection
Urine will be collected from all participants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Germany,  Mexico,  Poland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of individual serum biomarkers	Investigation of pathways which may be dysregulated in cutaneous lupus lesions	Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)	No
Secondary	The concentration of individual urine biomarkers	The presence of potential biomarkers of disease activity will be explored in urine.	Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)	No
Secondary	The concentration of individual skin biomarkers	The presence of potential biomarkers of disease activity will be explored in blood.	Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)	No