A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out how safe and effective an investigational drug called alefacept (amevive) is for the treatment of moderate to severe erosive mucosal lichen planus.

Lichen planus is a skin disease that can last a long time and cause significant pain, itching, and scarring. It can affect the mucous membranes (area inside the mouth and vagina) and these areas can become erosive (sores can develop). Currently there is no known cure for this disease.

An investigational drug is one that has not been approved by the United States (US) Food and Drug Administration (FDA) to treat a particular condition or disease. Alefacept has been approved to treat psoriasis (a scaly skin rash). A number of reports suggest that lichen planus develops for some of the same reasons as psoriasis, but alefacept is not yet approved for the treatment of psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Biogen; Brigham and Women's Hospital; Stanford University
• Treatments: Alefacept

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