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

• ClinicalTrials.gov Identifier: NCT02034344
• Recruitment Status: Completed
• First Posted: January 13, 2014
• Last Update Posted: December 16, 2016
• Sponsor: Janssen Research & Development, LLC
• 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

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

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

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