A Multi-Center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus

Condition(s) targeted: Lichen Planus

Intervention: etanercept (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Wake Forest University

Official(s) and/or principal investigator(s):
Joseph Jorizzo, MD, Principal Investigator, Affiliation: Wake Forest University

This is a research study whose purpose is to test the effectiveness of etanercept (Enbrel) in the treatment of moderate to severe lichen planus. No studies have been done on the effectiveness of etanercept in lichen planus, although etanercept has been tested and used on other medical conditions. Etanercept has not been FDA approved for the treatment of lichen planus.

Official title: A Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Etanercept 50 mg Twice Weekly Versus Etanercept 25 mg Twice Weekly Versus Placebo in the Treatment of Lichen Planus

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study

Primary outcome: The percentage of patients achieving a response in mucosal disease (or cutaneous disease if no mucosal disease) at 12 weeks.

Secondary outcome: The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks.

Detailed description: Lichen planus is a chronic, inflammatory skin disease which can be particularly difficult to treat. The exact cause of lichen planus is not clear, but a number of studies suggest that immune system cells called T lymphocytes play a role through abnormally increased activity. Etanercept is a drug which helps to maintain proper T lymphocyte activity and has been FDA approved for the treatment of psoriasis, another skin condition known to be caused by T cells with abnormally increased activity. There is no known cure for lichen planus. We hope to learn if etanercept represents an effective and safe treatment for lichen planus.

This research study is looking for 64 people with lichen planus. The study will be conducted at 12 sites across the United States. Approximately 5 subjects will be enrolled at this site.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- At least 18 years of age.

- Must carry a diagnosis of lichen planus as determined by either a skin or mucosal

biopsy

- Patients must have a score of 3 or greater (moderate-severe) on the PGA for cutaneous

or mucosal disease

- Patient must be considered appropriate for systemic therapy based upon fulfilling one

of the following criteria:

- inability to maintain weight due to pain with eating, chewing, or swallowing;

- dyspareunia or dysuria due to genital lesions;

- itch/pain of sufficient severity that activities of daily living are significantly

affected—this includes sleeping, cleansing oneself, performing one's occupation.

Exclusion Criteria:

- Known HIV-positive status, any other immuno-suppressive disease, or inability to

practice safe sex during the length of the study

- Subject has been diagnosed with a malignancy within the past 5 years except for

successfully treated non-melanoma skin cancer or in-situ cervical carcinoma.

- Subject has signs or symptoms of a lymphoproliferative disease.

- Other skin or mucosal disease that might interfere with lichen planus assessments,

including signs of squamous cell carcinoma.

- Lichen planus variants including hypertrophic, atrophic, follicular (including lichen

planopilaris), and bullous cutaneous forms.

Wake Forest University Health Sciences Dermatology, Winston Salem, North Carolina 27157, United States

Starting date: March 2007
Ending date: September 2008
Last updated: June 10, 2008