Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034344
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date December 10, 2013
First Posted Date January 13, 2014
Last Update Posted Date December 16, 2016
Study Start Date October 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2014)
The concentration of individual serum biomarkers [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 10, 2014)
  • The concentration of individual urine biomarkers [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
Official Title Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy participants and participants with Discoid Lupus Erythematosus (DLE)/Subacute Cutaneous Lupus Erythematosus (SCLE) without Systemic Lupus Erythematosus (SLE) and DLE/SCLE with SLE will be observed.
Condition
  • Lupus Erythematosus, Cutaneous
  • Lupus Erythematosus, Systemic
  • Lupus Erythematosus, Discoid
  • Healthy
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.
  • 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.
Study Groups/Cohorts
  • Group 1: Healthy participants
    20 healthy participants will be enrolled.
    Interventions:
    • Procedure: Skin biopsy
    • Procedure: Blood collection
    • Procedure: Urine collection
  • 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.
    Interventions:
    • Procedure: Skin biopsy
    • Procedure: Blood collection
    • Procedure: Urine collection
  • Group 3: DLE/SCLE with SLE
    30 participants with DLE/SCLE with SLE will be enrolled.
    Interventions:
    • Procedure: Skin biopsy
    • Procedure: Blood collection
    • Procedure: Urine collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2015)
77
Original Estimated Enrollment
 (submitted: January 10, 2014)
80
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Mexico,   Poland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02034344
Other Study ID Numbers CR102355
NOCOMPOUNDLUP0001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor Janssen Research & Development, LLC
Collaborators Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date December 2016