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To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.
This is a single center, exploratory, open-label, single-arm design study of 12 patients. Treatment naïve and treatment refractory patients with LP will be treated with INCB018424 PHOSPHATE CREAM. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. The study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). The screening and washout period will allow for treatment naïve/ new diagnosis LP to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. The total duration of the study will be 13-16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB018424 | Experimental | INCB018424 Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB018424 | Drug | INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) | mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity | week 0, week 4 |
| Change in Total Body Lesion Count | The number of total body lesions. | week 0, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pruritus Numerical Rating Scale | Pruritus Numerical Rating Scale as measured by they question "How severe has your itching been over the last 24 hours?" Ranging from 0 = none, to 10 = severe. The higher the score the more severe. | week 0, week 4 |
| Change in Overall Quality of Life Skindex-16 Score |
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Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator.
Subjects must give written, signed, and dated informed consent before any study related activity is performed.
When appropriate, a legal representative will sign the informed consent according to local laws and regulation
Both men and women must be at least 18 years of age at the time of screening
Subjects must have clinical and histological features of LP
LP must involve between 2 and 20% of the BSA
Subjects must have a minimum of 10 lesions of LP
Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP
Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid
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| Name | Affiliation | Role |
|---|---|---|
| Aaron R Mangold | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35131254 | Derived | Brumfiel CM, Patel MH, Severson KJ, Zhang N, Li X, Quillen JK, Zunich SM, Branch EL, Nelson SA, Pittelkow MR, Mangold AR. Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. J Invest Dermatol. 2022 Aug;142(8):2109-2116.e4. doi: 10.1016/j.jid.2022.01.015. Epub 2022 Feb 5. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | INCB018424 | Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | INCB018424 | Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) | mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity | Posted | Mean | Standard Deviation | score on a scale | week 0, week 4 |
|
|
Adverse Events were collected from baseline to end of study, approximately 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 | INCB018424 | Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Taste | Nervous system disorders | Systematic Assessment |
All subjects reached the 4 week endpoint. Due to surrounding the Covid-19 pandemic, 2 subjects did not complete weeks 8 or 12 and 1 subject did not complete week 12.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron R. Mangold, M.D. | Mayo Clinic | 480-301-6479 | Mangold.Aaron@mayo.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 | May 29, 2020 | Apr 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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Topical INCB018424
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Skindex-16 score as measured by 16 questions, 3 subscales: Symptoms, Emotional, Functional. Score ranges for each question (0-6). Total score ranging from 0-96 with higher score indicating worse quality of life |
| week 0, week 4 |
| Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score | PGA score as measured by Grade 0 (clear: no evidence of disease (100% improvement)) to Grade 6 (Worse, disease is worse than at baseline evaluation by (≥25%) or more). Higher score equals worse disease | week 0, week 4 |
| Body Surface Area (BSA) Affected by Cutaneous Lichen Planus | BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body. | week 0, week 4 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Disease | Mean | Standard Deviation | years |
|
| Number of Prior Treatments | Mean | Standard Deviation | prior treatments |
|
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| Primary | Change in Total Body Lesion Count | The number of total body lesions. | Posted | Median | Inter-Quartile Range | lesions | week 0, week 4 |
|
|
|
| Secondary | Change in Pruritus Numerical Rating Scale | Pruritus Numerical Rating Scale as measured by they question "How severe has your itching been over the last 24 hours?" Ranging from 0 = none, to 10 = severe. The higher the score the more severe. | Posted | Mean | Standard Deviation | score on a scale | week 0, week 4 |
|
|
|
| Secondary | Change in Overall Quality of Life Skindex-16 Score | Skindex-16 score as measured by 16 questions, 3 subscales: Symptoms, Emotional, Functional. Score ranges for each question (0-6). Total score ranging from 0-96 with higher score indicating worse quality of life | Posted | Mean | Standard Deviation | score on a scale | week 0, week 4 |
|
|
|
| Secondary | Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score | PGA score as measured by Grade 0 (clear: no evidence of disease (100% improvement)) to Grade 6 (Worse, disease is worse than at baseline evaluation by (≥25%) or more). Higher score equals worse disease | Posted | Number | participants | week 0, week 4 |
|
|
|
| Secondary | Body Surface Area (BSA) Affected by Cutaneous Lichen Planus | BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body. | Posted | Mean | Standard Deviation | mean percentage of body surface area | week 0, week 4 |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| Blood Clot | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cold | General disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Incontinence | Renal and urinary disorders | Systematic Assessment |
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| Light headedness | Nervous system disorders | Systematic Assessment |
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| Sleep Disturbance | Psychiatric disorders | Systematic Assessment |
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| Pressure on right arm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sinus Infection | Infections and infestations | Systematic Assessment |
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| Vaginal Infection | Infections and infestations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Yeast Infection | Infections and infestations | Systematic Assessment |
|
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