Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Exploratory Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04908280

Enrollment

Registered

2021-06-01

Start date

2022-05-04

Completion date

2024-03-04

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discoid Lupus Erythematosus

Brief summary

The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)

Interventions

DRUGRuxolitinib

1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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%.

Exclusion criteria

* 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. * 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

Design outcomes

Primary

Measure	Time frame	Description
Mean Severity of Disease as Measured by the Investigator's Global Assessment	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.

Secondary

Measure	Time frame	Description
Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)	Baseline to 12 weeks	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.
Mean Change in Itch Symptoms	Baseline to 12 weeks	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.
Mean Change in Pain Symptoms	Baseline to 12 weeks	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.
Mean Change in Melanin Index Score	Baseline to 12 weeks	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.
Mean Change in Erythema Index Score	Baseline to 12 weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Discoid Lupus Erythematosus Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks. Ruxolitinib: 1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions.	10
Total	10

Baseline characteristics

Characteristic	Discoid Lupus Erythematosus
Age, Continuous	49.9 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Mean itch symptoms	2.8 score on a scale STANDARD_DEVIATION 4.12
Mean pain symptoms	1.2 score on a scale STANDARD_DEVIATION 3.16
Mean severity of disease as measured by the Investigator's Global Assessment	3.0 score on a scale STANDARD_DEVIATION 0
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	7 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	3 Participants
Region of Enrollment United States	10 participants
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	0 / 10
serious Total, serious adverse events	0 / 10

Outcome results

Primary

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 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.

Time frame: 12 weeks

Arm	Measure	Value (MEAN)	Dispersion
Discoid Lupus Erythematosus	Mean Severity of Disease as Measured by the Investigator's Global Assessment	1.4 score on a scale	Standard Error 0.84

Secondary

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.