Lupus Erythematosus, CutaneousNCT02034344
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
An observational study of Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 21 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid
- What is being tested?
- Skin biopsy, Blood collection and Urine collection
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Oct 2013to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States9 sites
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Duncansville, Pennsylvania
Study site
La Jolla, California
Study site
Lansing, Michigan
Study site
Neptune City, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
Salt Lake City, Utah
Mexico3 sites
Study site
Chihuahua City
Study site
Jalisco
Study site
Mexico City
About this study
Official title: Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
Read the 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.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy
- Being tested
- Skin biopsy, Blood collection, Urine collection
- Keywords
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy, Active Cutaneous Lupus Erythematosus, Longitudinal Study, Biomarkers, Subacute Cutaneous Lupus Erythematosus, Skin Biopsy
- Medical subject headings
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
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 collectionProcedure or surgery
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 collectionProcedure or surgery
Urine will be collected from all participants.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Healthy participants | 20 healthy participants will be enrolled. Receives: 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. Receives: 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. Receives: Procedure: Skin biopsy; Procedure: Blood collection; Procedure: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of individual serum biomarkers
Investigation of pathways which may be dysregulated in cutaneous lupus lesions
Measured: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Secondary outcomes (2)
The concentration of individual urine biomarkers
The presence of potential biomarkers of disease activity will be explored in urine.
Measured: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
The concentration of individual skin biomarkers
The presence of potential biomarkers of disease activity will be explored in blood.
Measured: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, CutaneousStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034344
- Sponsor's protocol ID
- CR102355
- Other IDs
- NOCOMPOUNDLUP0001
- Status last verified
- Dec 2016
- First submitted
- 10 Dec 2013
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Skin And Systemic Biomarkers In Subjects With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02034344
- Acronym / sponsor ID
- CR102355
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy
- Keywords
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy, Active Cutaneous Lupus Erythematosus, Longitudinal Study, Biomarkers, Subacute Cutaneous Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Healthy participants | – | Procedure: Skin biopsy, Procedure: Blood collection, Procedure: Urine collection20 healthy participants will be enrolled. |
| Group 2: DLE/SCLE without SLE | – | Procedure: Skin biopsy, Procedure: Blood collection, Procedure: Urine collection30 participants with Discoid Lupus Erythematosus/Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) without Systemic Lupus Erythematosus (SLE) will be enrolled. |
| Group 3: DLE/SCLE with SLE | – | Procedure: Skin biopsy, Procedure: Blood collection, Procedure: Urine collection30 participants with DLE/SCLE with SLE will be enrolled. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsyParticipants 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 or surgery | Group 1: Healthy participants, Group 2: DLE/SCLE without SLE, Group 3: DLE/SCLE with SLE |
| Blood collectionBlood 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 or surgery | Group 1: Healthy participants, Group 2: DLE/SCLE without SLE, Group 3: DLE/SCLE with SLE |
| Urine collectionUrine will be collected from all participants. | Procedure or surgery | Group 1: Healthy participants, Group 2: DLE/SCLE without SLE, Group 3: DLE/SCLE with SLE |
Primary outcome
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
2 secondary outcomes
The concentration of individual urine biomarkers
Time frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
The concentration of individual skin biomarkers
Time frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
Related trials for Lupus Erythematosus, Cutaneous
Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, run by Janssen Research & Development, LLC at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Mexico, Poland, Germany, Taiwan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of individual serum biomarkers (time frame: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.