Discoid Lupus ErythematosusPhase 2NCT04908280
Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
A Phase 2 study testing Ruxolitinib in people with Discoid Lupus Erythematosus, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discoid Lupus Erythematosus
- What is being tested?
- Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to 4 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and comply with the protocol and provide informed consent.
- Speaks English.
- Age ≥ 18 years.
- Clinical diagnosis of discoid lupus as assessed by the PI.
- At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with a diameter ≥ 1cm at screening and baseline. Two lesions with equal scores will be necessary if consenting to pre-and post-treatment biopsies.
- Maximum body surface area of 20%.
Who cannot join
- Unwillingness or inability to complete informed consent process or comply with the study protocol.
- Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study.
- History of coagulopathy, pulmonary embolism or deep venous thrombosis.
- History of cutaneous squamous cell carcinoma localized to the treatment area.
- Serum creatinine > 1.5 mg/dL, or alanine aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal.
- Other dermatologic disease besides discoid lupus whose presence or treatments could complicate assessments.
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- Other diseases besides dermatologic disorders whose treatment could complicate assessments. Subjects with systemic lupus erythematosus are permitted as long as they do not have unstable disease and meet all other criteria, including the exclusion criteria for systemic immunosuppressive or immunomodulating drugs (below).
- Topical treatments for discoid lupus within 2 weeks of Visit 2.
- Systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) other than antimalarials (hydroxychloroquine, chloroquine, quinacrine) within 4 weeks or 5 half-lives of Visit 2 (whichever is longer).
- Potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before Visit 2 (topical agents with limited systemic availability are permitted).
- Prior use of JAK inhibitors, systemic or topical, within the last 12 months.
- Ultraviolet (UV) therapy or tanning within 2 weeks prior to Visit 2 or during the duration of the treatment period.
- Any systemic or local infection that, in the opinion of the investigator, may compromise the safety of the subject or complicate assessments.
- Subjects allergic to lidocaine or with a history of keloids will not be allowed to provide an optional skin biopsy, but will be eligible for the remainder of the study.
- Electrocardiogram (ECG) changes on baseline screening consistent with high risk for a major adverse cardiovascular event (MACE).
Trial locations and contacts
1 site in 1 country.
United States1 site
UR Medicine Dermatology College Town
Rochester, New York, 14642
About this study
Official title: Exploratory Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)
- Conditions
- Discoid Lupus Erythematosus
- Being tested
- Ruxolitinib
- Medical subject headings
- Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions.
| Study group | Role | What they receive |
|---|---|---|
| Discoid lupus erythematosus | Experimental | Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks. Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Severity of Disease as Measured by the Investigator's Global Assessment
The Investigator's Global Assessment will be performed at study visits 2-6. The IGA is an instrument to rate the severity of the subject's global disease. This IGA is comprised of a 5-point scale of disease activity ranging from 0 to 4 as follows: 0: "clear," no erythema or scale
- "almost clear," pink erythema without scale
- "mild," pink erythema with scale
- "moderate," red erythema with scale
- "severe," purple/violaceous or hemorrhagic/crusted erythema OR hypertrophic/ verrucous scale
Range of scores are 0-4 with higher scores indicating worse outcome.
Measured: 12 weeks
Secondary outcomes (5)
Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)
The Cutaneous Lupus Area and Severity Index (CLASI) will be performed at study visits 2-6. This is a validated measurement instrument designed for use in clinical trials to assess disease activity and damage in subjects with cutaneous lupus. The CLASI is comprised of two parts, CLASI-A that measures disease activity (erythema and scale), and CLASI-D that measures disease damage (pigmentation and scarring).
CLASI-A scores range from 0 to 70 with higher scores indicating worse outcomes.
Measured: Baseline to 12 weeks
Mean Change in Itch Symptoms
Subjects will maintain a symptom diary every day for 12 weeks. Specifically, subjects will rate pain and itch separately using a numeric rating scale (NRS) and the questions below. Symptom diaries will be reviewed at study visits 2-6. "On a scale of "no itch" (0) to "worst imaginable itch" (10), how was your worst itch in the 24 hours?"
Scores will range from 0-10 with higher scores indicating worse outcome.
Measured: Baseline to 12 weeks
Mean Change in Pain Symptoms
Subjects will maintain a symptom diary every day for 12 weeks. Specifically, subjects will rate pain and itch separately using a numeric rating scale (NRS) and the questions below. Symptom diaries will be reviewed at study visits 2-6.
"On a scale of "no skin pain" (0) to "worst imaginable skin pain" (10), how was your worst skin pain in the 24 hours?"
Scores will range from 0-10 with higher scores indicating worse outcome.
Measured: Baseline to 12 weeks
Mean Change in Melanin Index Score
Photographs of all discoid lesions will be taken at baseline and week 12. The Haiku app will be used to directly load photos into the secure Epic medical record system. Images will be extracted from Epic, and analyzed. In brief, a melanin index (MI) will be generated for each lesion using Image J software analysis. The measurement will be a ratio comparing the pigmentation of the lesion to non-lesion skin. The analysis uses perilesional skin to normalize the photograph.
Measurements will range from 0 to 10. Scores further from a score of 1 will indicate more severe outcomes.
Measured: Baseline to 12 weeks
Mean Change in Erythema Index Score
Photographs of all discoid lesions will be taken at baseline and week 12. The Haiku app will be used to directly load photos into the secure Epic medical record system. Images will be extracted from Epic, and analyzed. In brief, an erythema index (EI) will be generated for each lesion using Image J software analysis. The measurement will be a ratio comparing the erythema of the lesion to non-lesion skin. The analysis uses perilesional skin to normalize the photograph.
Measurements will range from 0 to 10. Scores further from a score of 1 will indicate more severe outcomes.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start4 May 2022
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Discoid Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, Christopher T Richardson MD, PhD, University of Rochester
- Investigators
- Christopher T Richardson, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908280
- Sponsor's protocol ID
- STUDY00006186
- Status last verified
- May 2025
- First submitted
- 26 May 2021
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04908280
- Acronym / sponsor ID
- STUDY00006186
- Conditions
- Discoid Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 4 May 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 20 May 2025
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 assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discoid lupus erythematosus | Experimental | Drug: RuxolitinibPatients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and comply with the protocol and provide informed consent.
- Speaks English.
- Age ≥ 18 years.
- Clinical diagnosis of discoid lupus as assessed by the PI.
- At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with a diameter ≥ 1cm at screening and baseline. Two lesions with equal scores will be necessary if consenting to pre-and post-treatment biopsies.
Key exclusion criteria (15 listed)
- Unwillingness or inability to complete informed consent process or comply with the study protocol.
- Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study.
- History of coagulopathy, pulmonary embolism or deep venous thrombosis.
- History of cutaneous squamous cell carcinoma localized to the treatment area.
- Serum creatinine > 1.5 mg/dL, or alanine aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal.
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 |
|---|---|---|
| Ruxolitinib1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions. | Drug | Discoid lupus erythematosus |
Primary outcome
Mean Severity of Disease as Measured by the Investigator's Global Assessment
Time frame: 12 weeks
The Investigator's Global Assessment will be performed at study visits 2-6. The IGA is an instrument to rate the severity of the subject's global disease. This IGA is comprised of a 5-point scale of disease activity ranging from 0 to 4 as follows: 0: "clear," no erythema or scale 1. "almost clear," pink erythema without scale 2. "mild," pink erythema with scale 3. "moderate," red erythema with scale 4. "severe," purple/violaceous or hemorrhagic/crusted erythema OR hypertrophic/ verrucous scale Range of scores are 0-4 with higher scores indicating worse outcome.
5 secondary outcomes
Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)
Time frame: Baseline to 12 weeks
Mean Change in Itch Symptoms
Time frame: Baseline to 12 weeks
Mean Change in Pain Symptoms
Time frame: Baseline to 12 weeks
Mean Change in Melanin Index Score
Time frame: Baseline to 12 weeks
Mean Change in Erythema Index Score
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Discoid Lupus Erythematosus
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A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
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Active, not recruitingPhase 2
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
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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.
Christopher T Richardson, MD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib in people with Discoid Lupus Erythematosus, run by University of Rochester at 1 site in United States.
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 6 inclusion and 15 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Severity of Disease as Measured by the Investigator's Global Assessment (time frame: 12 weeks). 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 20 May 2025.