Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to assess the response of subjects to etanercept (as compared to placebo) in treating the physical signs of mucosal and cutaneous lichen planus. The investigators also wish to assess the effect of etanercept on disease-related itching, pain, and serious adverse events in patients with lichen planus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Emory University; Fivenson, David, M.D.; Icahn School of Medicine at Mount Sinai; Oregon Health and Science University; The Cleveland Clinic; Tufts Medical Center; University Hospitals Cleveland Medical Center; University of Louisville; University of Michigan; Wake Forest School of Medicine; Wake Forest University Health Sciences; Wright State University
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• At least 18 years old.

• Must carry a diagnosis of lichen planus as determined by biopsy

• Patients must have a score of 3 or greater on the physician global assessment (PGA).

• Patient must be considered appropriate for systemic therapy based upon fulfilling one of the following criteria:

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

2. dyspareunia or dysuria due to genital lesions;

3. itch/pain of sufficient severity that activities of daily living are significantly affected

• Must be off systemic lichen planus treatment for 4 weeks prior to starting etanercept

• 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.

• Must be off topical cyclosporine, tacrolimus, or pimecrolimus for 2 weeks prior to starting the study drug and for the entire duration of the study.

• Must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information.

• Women of childbearing potential must have a negative pregnancy test at the time of entry into the study and must be practicing successful contraception for at least 3 months prior to the study.

• Subject or designee must have the ability to self-inject investigational product.

• Screening laboratory results are within the following parameters:

• Hemoglobin > 10 g/dL

• White blood cells > 3.5 x 10^9/L

• Neutrophils > 1.5 x 10^9/L

• Platelets > 100 x 10^9/L

• Lymphocytes > 0.5 x 10^9/L

• Serum creatinine < 1.5 mg/dL

• Hepatitis C serology - nonreactive

• AST and ALT < 2X upper limit of normal (ULN)

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

• Subject has signs or symptoms of a lymphoproliferative disease.

• Other skin or mucosal disease that might interfere with lichen planus assessments.

• 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

• History of tuberculosis (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 (CHF) of any severity

• Use of a live vaccine 90 days prior to, or during this study.

• Previous exposure and/or known sensitivity to etanercept

• 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, 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 > 0.5 g

• Symptomatic liver disease with serum albumin < 3 G/DL

• PT or PTT > ULN, or

• Chronic liver disease

• Documented forced vital capacity < 50% of predicted