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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discoid lupus erythematosus | Experimental | Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | 1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
Range of scores are 0-4 with higher scores indicating worse outcome. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher T Richardson, MD, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UR Medicine Dermatology College Town | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
Range of scores are 0-4 with higher scores indicating worse outcome. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher T Richardson MD, PhD | University of Rochester | 585 - 275 - 7546 | crichardson@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 | Nov 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2023 | Nov 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008179 | Lupus Erythematosus, Discoid |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Baseline to 12 weeks |
| 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. | Baseline to 12 weeks |
| 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. | Baseline to 12 weeks |
| Mean Change in Melanin 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, 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. | Baseline to 12 weeks |
| 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. | Baseline to 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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
Range of scores are 0-4 with higher scores indicating worse outcome. | Mean | Standard Deviation | score on a scale |
|
| Mean 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 | Standard Deviation | score on a scale |
|
| Mean 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 | Standard Deviation | score on a scale |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of change in disease activity | Baseline to 12 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| Secondary | Mean Change in Melanin 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, 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks | photographs | photographs |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks | photographs | photographs |
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