Expired Study
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Stanford, California 94305


Purpose:

The purpose of this study is to determine the safety and efficacy of etanercept (also known as Enbrel) in the treatment of moderate to severe lichen planus.


Study summary:

This is a double-blind, placebo-controlled pilot study to observe the safety and efficacy of etanercept in patients with moderate to severe oral or cutaneous lichen planus. Etanercept has already been approved by the FDA for treatment of other diseases including psoriasis. This study will evaluate its safety and effectiveness specifically in treating lichen planus. Several lines of evidence suggest that TNF-alpha plays a role in the pathogenesis of lichen planus. Because etanercept inhibits tumor necrosis factor, this represents a potentially effective therapeutic intervention for diseases in which the role of TNF-alpha is implicated, such as lichen planus. The study will involve 8 total clinic visits over 6 months. Eligible subjects will be randomized either to a treatment group or to a placebo group. The study is designed in three parts: - Part 1 (Weeks 1-12) During this time you will be assigned to either receive etanercept or a placebo twice weekly. You will have a fifty percent chance of receiving the study drug (etanercept). Neither you nor the staff will know what you are receiving during this time. - Part 2 (Weeks 13-24) During this time all patients who have not achieved complete clearance will have the opportunity to receive etanercept (the active drug), regardless of what group you were assigned to during Part 1. Those that were assigned to receive etanercept in Part 1 will receive a 50% lower dose of drug for the remainder of the study. - Part 3 (Weeks 25-32) During this follow-up period you will not be receiving any study drug. You must have the ability to self-inject the study drug or have a care giver at home who can administer the subcutaneous injections twice a week. A study staff will instruct you on proper injection technique at your baseline visit. Participants will be compensated $25 for every completed scheduled study visit for a total of $200 after the completion of the trial.


Criteria:

Inclusion Criteria:Adults over 18 years of age with active, clinically stable lichen planus with a score of 3 or greater on the physician global assessment for cutaneous or mucosal disease will be included in this trial. Subjects must also be considered appropriate for systemic treatment. Detailed inclusion criteria: 1. Subjects must be at least 18 years of age. 2. Must carry a diagnosis of lichen planus as determined by either a skin or mucosal biopsy 3. Patients must have a score of 3 or greater (moderate-severe) on the PGA for cutaneous or mucosal disease 4. 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 this includes sleeping, cleansing oneself, performing one's occupation. 5.Must be off systemic lichen planus treatment (e.g. cyclosporine, systemic retinoids, hydroxychloroquine, chlorquine, quinacrine, azathioprine, methotrexate, mycophenolate mofetil, dapsone, thalidomide, PUVA, UVB) for 4 weeks prior to starting the study drug. Prednisone may be continued during the study if it is at a dose of 10mg/day or less and if at a stable dose for at least 4 weeks prior to starting the study drug. 6.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. 7.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. 8.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. 9.Women of childbearing potential (i.e. does not include those surgically sterile or at least 5 years postmenopausal) must have a negative pregnancy test at the time of entry into the study (negative pregnancy test within 7 days before the first dose of study drug) 10.Women of child-bearing potential must be practicing successful contraception for at least 3 months prior to the study with one of the following methods (OCPs, IUDs, diaphragm, spouse or sexual partner uses condom or is surgically sterilized, abstinence). If using a hormonal form of contraception, the patient will be excluded if they have not used the same form of hormonal contraception for 90 days prior to the start of the etanercept (e.g. day 0) or are not willing to continue the use of the same form of hormonal contraception for the duration of the study. Sexual partners of a male participant shall have no childbearing potential or practice effective contraception during and for at least 8 weeks following completion of the study. 11.Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections (unless the study requirements are that all doses will be given at the clinic) 12.Screening laboratory results must be within the following parameters: - Hemaglobin > 10 g/dL - White blood cells > 3.5 x 109/L - Neutrophils> 1.5 x 109/L - Platelets> 100 x 109/L - Lymphocytes> 0.5 x 109/L - Serum creatinine< 1.5 mg/dL - HCV Antibody = Nonreactive - AST and ALT < 2X Upper Limit of Normal (ULN) Exclusion Criteria:1.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. 2.Known HIV-positive status, any other immuno-suppressive disease, or inability to practice safe sex during the length of the study 3.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. 4.Subject has signs or symptoms of a lymphoproliferative disease. 5.Other skin or mucosal disease that might interfere with lichen planus assessments, including signs of squamous cell carcinoma. 6.Lichen planus variants including hypertrophic, atrophic, follicular (including lichen planopilaris), and bullous cutaneous forms. 7.Patients with lichen sclerosis et atrophicus (LS&A) 8.Clinical history and lesion distribution suspicious for a lichenoid drug eruption 9.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 10.History of TB or positive PPD at screening (PPD more than 5 mm induration at 48-72h at screening, irrespective of BCG vaccination status). 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. 11.Subject has a diagnosis of congestive heart failure of any severity 12.Use of a live vaccine 90 days prior to, or during this study. 13.Previous exposure and/or known sensitivity to etanercept or to any of its components 14.Concurrent use, or failure of, any TNF-inhibitor 15.Previous exposure to alefacept or efalizumab within 6 weeks of administration of study drug 16.Concurrent sulfasalazine therapy 17.Prior or concurrent cyclophosphamide therapy 18.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. 19.Active inflammatory bowel disease or peptic ulcer disease 20.Drug or alcohol abuse within 12 months of screening visit. 21.History of non-compliance with other therapies 22.Pregnant or lactating 21. Documented presence of any of the following: proteinuria >1+ by dipstick screening, 24 hour protein excretion more than 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) 22. Documented Forced Vital Capacity < 50% of predicted


NCT ID:

NCT00568581


Primary Contact:

Principal Investigator
David Franklin Fiorentino
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States

Beth Sanderson, MD
Phone: 650-724-0964
Email: bsan@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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