Discoid Lupus Erythematosus
Conditions
Keywords
discoid lupus erythematosus, opzelura, ruxolitinib cream
Brief summary
This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
Detailed description
This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.
Interventions
Topical application of Ruxolitinib 1.5% cream
PROCEDUREApplication without occlusion in Area 1
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.
PROCEDUREApplication under occlusion at night in Area 2
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.
PROCEDUREApplication under occlusion at night in Area 1
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.
PROCEDUREApplication without occlusion in Area 2
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.
Sponsors
Innovaderm Research Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject.
Intervention model description
Intra-individual
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Subject has no known history of latent or active tuberculosis (TB) infection. * Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. * Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
Exclusion criteria
* 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. * Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots. * Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]). * Subject is known to have hepatitis B or hepatitis C viral infection. * Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. * Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab. * Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1. * Subject has a known or suspected allergy to ruxolitinib. * Subject has used ruxolitinib cream (OpzeluraTM). * Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1. * Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in target lesion CLASI-A score | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with an erythema score of 0 (absent) | Week 24 | 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 CLASI-A score | Week 12, Week 24 | 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. |
| Change from baseline in target lesion SADDLE-A | Week 12, Week 24 | 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) | Week 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale(NRS) | Weeks 12 and 24 | 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. |
| Cutaneous Lupus Erythematosus Quality of Life (CLEQol) | Weeks 12 and 24 | 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. |
| Dermatology Life Quality Index (DLQI) | Weeks 12 and 24 | 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. |
Countries
Canada
Contacts
Primary ContactFareheen Chowdhury
Outcome results
None listed