A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
Lichen Planus
About this trial
This is an interventional treatment trial for Lichen Planus focused on measuring Lichen Planus, Mucosal lichen planus, Alefacept, T-cell mediated, subcutaneous medication, Autoimmune disease
Eligibility Criteria
Key Inclusion Criteria: Written informed consent, authorize release and use of protected health information At least 18 years of age Diagnosis of moderate to severe mucosal lichen planus No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug. Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study. Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value Key Exclusion Criteria: Clinically significant abnormal laboratory values Skin lesions currently undiagnosed, but suspicious for malignancy Other skin disease that might interfere with lichen planus status assessments. History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment. Previous exposure to alefacept
Sites / Locations
- Clinical Unit for Research Trials in Skin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
A
B
Amevive
Placebo