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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02034344

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid Healthy	Procedure: Skin biopsy Procedure: Blood collection Procedure: Urine collection

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

77 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Group 1: Healthy participants 20 healthy participants will be enrolled.	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. Procedure: 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. Procedure: Urine collection Urine will be collected from all participants.
Group 2: DLE/SCLE without SLE 30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.	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. Procedure: 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. Procedure: Urine collection Urine will be collected from all participants.
Group 3: DLE/SCLE with SLE 30 participants with DLE/SCLE with SLE will be enrolled.	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. Procedure: 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. Procedure: Urine collection Urine will be collected from all participants.

Arm

Intervention/Treatment

Group 1: Healthy participants

20 healthy participants will be enrolled.

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.

Procedure: 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.

Procedure: Urine collection

Urine will be collected from all participants.

Group 2: DLE/SCLE without SLE

30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled.

Procedure: Skin biopsy

Procedure: 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.

Procedure: Urine collection

Urine will be collected from all participants.

Group 3: DLE/SCLE with SLE

30 participants with DLE/SCLE with SLE will be enrolled.

Procedure: Skin biopsy

Procedure: 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.

Procedure: Urine collection

Urine will be collected from all participants.

Outcome Measures

Primary Outcome Measures

The concentration of individual serum biomarkers [Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)]
Investigation of pathways which may be dysregulated in cutaneous lupus lesions

Secondary Outcome Measures

The concentration of individual urine biomarkers [Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)]
The presence of potential biomarkers of disease activity will be explored in urine.
The concentration of individual skin biomarkers [Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)]
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:

Yes

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

Contacts and Locations

Locations

	City	State	Country
1	La Jolla	California	United States
2	Chicago	Illinois	United States
3	Boston	Massachusetts	United States
4	Lansing	Michigan	United States
5	Neptune	New Jersey	United States
6	Charlotte	North Carolina	United States
7	Duncansville	Pennsylvania	United States
8	Philadelphia	Pennsylvania	United States
9	Salt Lake City	Utah	United States
10	Berlin		Germany
11	Kiel		Germany
12	Chihuahua		Mexico
13	Jalisco		Mexico
14	Mexico City		Mexico
15	Gdansk		Poland
16	Krakow		Poland
17	Wroclaw		Poland
18	Taichung		Taiwan
19	Taipei		Taiwan
20	Leeds		United Kingdom
21	London		United Kingdom