Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus
Condition: Lichen Planus
MeSH terms: Lichen Planus
Intervention: Etanercept; Placebo
Intervention description: etanercept 50 mg twice weekly for 12 weeks
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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