Trial Outcomes & Findings for Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus (NCT NCT04908280)

NCT ID: NCT04908280

Last Updated: 2025-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Discoid Lupus Erythematosus n=10 Participants 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.
Age, Continuous	49.9 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Mean severity of disease as measured by the Investigator's Global Assessment	3.0 score on a scale STANDARD_DEVIATION 0 • n=5 Participants
Mean itch symptoms	2.8 score on a scale STANDARD_DEVIATION 4.12 • n=5 Participants
Mean pain symptoms	1.2 score on a scale STANDARD_DEVIATION 3.16 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Discoid Lupus Erythematosus n=10 Participants 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.
Mean Severity of Disease as Measured by the Investigator's Global Assessment	1.4 score on a scale Standard Error 0.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Discoid Lupus Erythematosus n=10 Participants 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.
Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)	-30.2 percentage of change in disease activity Standard Deviation 25.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Discoid Lupus Erythematosus n=10 Participants 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.
Mean Change in Itch Symptoms	0.67 score on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Discoid Lupus Erythematosus n=10 Participants 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.
Mean Change in Pain Symptoms	0.67 score on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Discoid Lupus Erythematosus n=60 photographs 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.
Mean Change in Melanin Index Score baseline	2.28 score on a scale Standard Deviation 1.18
Mean Change in Melanin Index Score 12 weeks	2.73 score on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Discoid Lupus Erythematosus n=60 photographs 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.
Mean Change in Erythema Index Score baseline	1.87 score on a scale Standard Deviation 0.74
Mean Change in Erythema Index Score 12 weeks	1.18 score on a scale Standard Deviation 0.18

Adverse Events

Discoid Lupus Erythematosus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher T Richardson MD, PhD

University of Rochester

Phone: 585 - 275 - 7546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place