Trial Information

Summary: A Double-Blind, Randomized, Multicenter Pilot Study to Evaluate the Efficacy and Safety of Etanercept 50mg SC Twice Weekly in the Treatment of Moderate to Severe Lichen Planus

The Stanford University Department of Dermatology is seeking volunteers with moderate to severe lichen planus for a study testing the efficacy and safety of the drug etanercept (also known as Enbrel) for this disease. Participants must be at least 18 years old. The study requires 8 visits over 6 months, and patients will be compensated for participation. For more information, please call 650-724-7035 or e-mail us at skinstudies@yahoo.com.

Patient Inclusion Criteria

• Must carry a diagnosis of moderate to severe lichen planus as determined by either a skin or mucosal biopsy
• Must be at least 18 years of age
• Must be off systemic lichen planus treatment (e.g. cyclosporine, systemic retinoids, hydroxychloroquine, chlorquine, quinacrine, azathioprine, methotrexate, mycophenolate mofetil, dapsone, thalidomide, PUVA, UVB) except for prednisone for 4 weeks prior to starting the study drug
• If using topical corticosteroid to the affected areas, the dose and frequency must be unchanged for 2 weeks prior to beginning the study agent and during the course of the study.
• You must not be pregnant, nursing, or planning a pregnancy
• You must not have been diagnosed with a cancer within the past 5 years, have a history of TB or positive PPD (>5mm), history of active hepatits B or C, diagnosis of congestive heart failure, active severe infection, or active inflammatory bowel disease
• You must not have had use of a live vaccine 90 days prior to, or during the study.
• You must not have a previous exposure to or known sensitivity to etanercept or concurrent use, or failure of any TNF-inhibitor.
• You must not have previous exposure to alefacept or efalizumab within 6 weeks of administration of study drug.

Patient Exclusion Criteria

• Subject is currently enrolled in another investigational device or drug trial(s), or subject has received investigational agent(s) within 90 days of baseline visit.
• 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.
• Patients with lichen sclerosis et atrophicus (LS&A)
• Clinical history and lesion distribution suspicious for a lichenoid drug eruption
• Severe co-morbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (systolic blood pressure <80 mm Hg or > 180 mm Hg or diastolic blood pressure >110 mm Hg), oxygen-dependent severe pulmonary disease, history of TB or TB exposure or other mycobacterial disease
• History of TB or positive PPD at screening. Known history of active hepatitis B or C, or lupus, SLE, history of multiple sclerosis or prior episode of central nervous system demyelination, transverse myelitis, optic neuritis, epilepsy, psychiatric condition), or other chronic serious medical illnesses.
• Subject has a diagnosis of congestive heart failure of any severity
• Use of a live vaccine 90 days prior to, or during this study.
• Previous exposure and/or known sensitivity to etanercept or to any of its components
• Concurrent use, or failure of, any TNF-inhibitor
• Previous exposure to alefacept or efalizumab within 6 weeks of administration of study drug
• Concurrent sulfasalazine therapy
• Prior or concurrent cyclophosphamide therapy
• Active severe infections (see warning and contraindications in etanercept Package Insert), or prior infection requiring hospitalization or oral/intravenous antibiotics within 4 weeks before screening visit, or between the screening and baseline visits.
• Active inflammatory bowel disease or peptic ulcer disease
• Drug or alcohol abuse within 12 months of screening visit.
• History of non-compliance with other therapies
• Pregnant or lactating
• Documented presence of any of the following: proteinuria >1+ by dipstick screening, 24 hour protein excretion Го 0.5 g, symptomatic liver disease with serum albumin < 3 G/DL, PT or PTT > upper range of control values, or chronic liver disease (e.g. hepatitis B or C)
• Documented Forced Vital Capacity < 50% of predicted

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.