Back to resultsStudy of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
Primary Purpose
Discoid Lupus Erythematosus
Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
About this trial
This is an interventional treatment trial for Discoid Lupus Erythematosus
Eligibility Criteria
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 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).
Sites / Locations
- UR Medicine Dermatology College Town
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Discoid lupus erythematosus
Arm Description
Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks.
Outcomes
Primary Outcome Measures
Mean change in the 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.
Secondary Outcome Measures
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.
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.
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.
Mean change in melanin index
Photographs of all discoid lesions will be taken at study visits 2-6. 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
Photographs of all discoid lesions will be taken at study visits 2-6. 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.
Full Information
NCT ID
NCT04908280
First Posted
May 26, 2021
Last Updated
August 14, 2023
Sponsor
University of Rochester
Collaborators
Incyte Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04908280
Brief Title
Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
Official Title
Exploratory Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Discoid lupus erythematosus
Arm Type
Experimental
Arm Description
Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions.
Primary Outcome Measure Information:
Title
Mean change in the severity of disease as measured by the Investigator's Global Assessment
Description
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.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Mean percentage change in disease activity as measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)
Description
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.
Time Frame
Baseline to 12 weeks
Title
Mean change in itch symptoms
Description
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.
Time Frame
Baseline to 12 weeks
Title
Mean change in pain symptoms
Description
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.
Time Frame
Baseline to 12 weeks
Title
Mean change in melanin index
Description
Photographs of all discoid lesions will be taken at study visits 2-6. 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.
Time Frame
Baseline to 12 weeks
Title
Mean change in erythema index
Description
Photographs of all discoid lesions will be taken at study visits 2-6. 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.
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher T Richardson, MD, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UR Medicine Dermatology College Town
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
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