Topical INCB018424 Lichen Planus
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/16/2018 |
| Start Date: | August 30, 2018 |
| End Date: | July 2020 |
INCB018424 in the Treatment of Cutaneous Lichen Planus
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.
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.
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.
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
We found this trial at
1
site
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Aaron R Mangold
Phone: 480-301-4714
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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