This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
Male or female subject 18 years of age or older at the time of consent.
Confirmed DLE diagnosis.
Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.
Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1.
Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.
Subject is known to have immune deficiency or is immunocompromised.
Parallel
Ruxolitinib 1.5% cream
DrugTopical application of Ruxolitinib 1.5% cream
Application without occlusion in Area 1
Procedure/SurgeryApply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.
Application under occlusion at night in Area 2
Procedure/SurgeryApply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.
Application under occlusion at night in Area 1
Procedure/SurgeryApply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.
Application without occlusion in Area 2
Procedure/SurgeryApply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.
Change from baseline in target lesion CLASI-A score
The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated with occlusion The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Change from baseline in target lesion CLASI-A score
The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated without occlusion. The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Proportion of subjects with an erythema score of 0 (absent)
Proportion of subjects with an erythema score of 0 (absent) in 50% of all DLE lesions. Erythema will be assessed for each DLE lesion identified on Day 1 using the erythema component of the CLASI-A scale. The severity of erythema is scored on a 4-point scale ranging from 0 (absent) to 3.
Change from baseline in target lesion SADDLE-A
Change from baseline in target lesion SADDLE-A at Week 24 for the target DLE lesion treated with and without occlusion. Change from baseline in target lesion SADDLE-A score at Week 12 for the untreated target DLE lesion and the target DLE lesion treated with and without occlusion
Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)
Proportion of subjects with a CLA-IGA score of 0 (clear) or 1 (almost clear) for all DLE lesions. The CLA-IGA is a 5 point scale that evaluates the severity of signs of the overall disease activity based on erythema, scale, edema/ infiltration, follicular involvement, and secondary changes.
Dermatology Life Quality Index (DLQI)
Change from baseline in DLQI. Quality of life will be evaluated using Dermatology Life Quality Index (DLQI). It is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomized controlled trials in dermatology.
Cutaneous Lupus Erythematosus Quality of Life (CLEQol)
Change from baseline in CLEQoL total score.Quality of life will be evaluated using the Cutaneous Lupus Erythematosus Quality of Life (CLEQoL).The CLEQoL asks subjects to assess how often (never, rarely, sometimes, often, all the time) they experienced a given effect. Scores of 0 (never), 25 (rarely), 50 (sometimes), 75 (often), or 100 (all the time) are assigned to each question. The scores are averaged per domain from the scale of 0-100, with higher numbers indicating worse quality of life.
Numeric Rating Scale(NRS)
Change from baseline in target lesion pruritus NRS scores.Pruritus numeric rating scale (NRS) will also be evaluated as an efficacy assessment for each of the 2 (or 3, as applicable) target lesions.This will be evaluated by asking subjects to assign a numerical score representing worst itch intensity over the last 24 hours of each target lesion on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch.
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