Lichen Planus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGINCB018424
INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Sponsors
Aaron R. Mangold
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Topical INCB018424
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Body Lesion Count | week 0, week 4 | The number of total body lesions. |
| Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) | week 0, week 4 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pruritus Numerical Rating Scale | week 0, week 4 | 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. |
| Change in Overall Quality of Life Skindex-16 Score | week 0, week 4 | 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 |
| Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score | week 0, week 4 | 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 |
| Body Surface Area (BSA) Affected by Cutaneous Lichen Planus | week 0, week 4 | BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INCB018424 Subjects applied INCB018424 topically, twice daily.
INCB018424 Cream
INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | INCB018424 |
|---|---|
| Age, Continuous | 63 years |
| Duration of Disease | 1.25 years STANDARD_DEVIATION 1.13 |
| Number of Prior Treatments | 2.2 prior treatments STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Caucasian | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 7 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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
Time frame: week 0, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCB018424 | Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) | 11.0 score on a scale | Standard Deviation 6.2 |
Primary
Change in Total Body Lesion Count
The number of total body lesions.
Time frame: week 0, week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INCB018424 | Change in Total Body Lesion Count | 50 lesions |
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.
Time frame: week 0, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INCB018424 | Body Surface Area (BSA) Affected by Cutaneous Lichen Planus | Week 0 | 6.1 mean percentage of body surface area | Standard Deviation 7.9 |
| INCB018424 | Body Surface Area (BSA) Affected by Cutaneous Lichen Planus | Week 4 | 0.9 mean percentage of body surface area | Standard Deviation 1.9 |
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
Time frame: week 0, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCB018424 | Change in Overall Quality of Life Skindex-16 Score | 36.3 score on a scale | Standard Deviation 17.5 |
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.
Time frame: week 0, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCB018424 | Change in Pruritus Numerical Rating Scale | 4.4 score on a scale | Standard Deviation 3 |
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
Time frame: week 0, week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCB018424 | Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score | 12 participants |