Clinical Trial: Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:

Lichen planus affects up to 1% of the worldwide population. Recent estimates suggest approximately 0.44% of the US population suffers from this disease. Oral or genital involvement occurs in 60-70% of patients, and it may be the sole manifestation of disease in 20-30% of patients.

Lichen planus is a mucocutaneous disorder that can involve the skin, oral or genital mucosa, conjunctiva, and nails. On the skin, the disease presents as multiple papules, which can be localized or generalized, that are often extremely itchy. Mucosal disease can consist of either asymptomatic plaques or extremely painful erosive lesions. The disease course is unpredictable and typically lasts 1-2 years but can follow a chronic, relapsing course. Erosive mucosal disease is important to aggressively treat for many reasons: First, the associated pain can be debilitating for the patient. Patients with severe oral lichen planus can become malnourished due to pain associated with eating. Vulvar disease can cause dyspareunia, burning pain, and discharge; second, the disease tends to be chronic, with little chance for self-resolution; third, erosive disease is associated with an increased risk of squamous cell carcinoma in the affected areas. These cancers occur in up to 1% of patients over a 3-year period, and they can be aggressive and even-life threatening for the patient if not recognized and treated early.

Several lines of evidence suggest that TNF-alpha plays a role in the pathogenesis of lichen planus. It has been shown that there are increased levels of TNF-alpha in the serum of these patients. In addition, skin and mucosal biopsies show increased TNF-alpha produced by the infiltrating lymphocytes as well as the basal keratinocytes. It has been suggested that the expression of TNF-alpha receptor on the basal keratinocytes may contribute to apopto
Sponsor: Stanford University

Current Primary Outcome: The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks [ Time Frame: 12 weeks ]

This is a physician global assessment of disease (0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease). The subject have a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.


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

Current Secondary Outcome:

  • The Percentage of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks [ Time Frame: 24 weeks ]
  • The Physician Assessment of Surface Area of Disease, PSAD, (Mucosal Erosions and Cutaneous Disease) at 12 and 24 Weeks [ Time Frame: 24 weeks ]
  • The Individual and Total Cutaneous Target Lesion Scores at 12 and 24 Weeks [ Time Frame: 12 weeks and 24 weeks ]
  • Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks [ Time Frame: 12 and 24 weeks ]
  • Patient Assessment of Pruritus/Itching on a Visual Analogue Scale (VAS) at 12 and 24 Weeks [ Time Frame: 12 and 24 weeks ]
  • Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks [ Time Frame: 12 and 24 weeks ]
  • The Number and Percentage of Subjects Experiencing Serious Adverse Events (SAE) on Etanercept and Placebo [ Time Frame: 12 and 24 weeks ]
  • The Percentage of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of "Clear") at 12 Weeks [ Time Frame: 12 weeks ]
  • The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24 [ Time Frame: 24 weeks ]


Original Secondary Outcome:

  • - The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks.
  • - The physician assessment of surface area of disease, PSAD, (mucosal erosions and cutaneous disease) at 12 and 24 weeks.
  • - The individual and total cutaneous target lesion scores at 12 and 24 weeks.
  • - Patient assessment of pain on a visual analogue scale (VAS) at 12 and 24 weeks.
  • - Patient assessment of pruritus/itching on a visual analogue scale (VAS) at 12 and 24 weeks.
  • - Patient assessment of overall disease severity (Patient Global Assessment) at 12 and 24 weeks.
  • - The number and percentage of subjects experiencing serious adverse events (SAE) on etanercept and placebo.
  • - The percentage of placebo patients who do not have a complete response (defined as a physician global assessment of “clear”) at 12 weeks.
  • - The percentage of placebo and study-drug patients able to discontinue use of topical corticosteroids through week 24.


Information By: Stanford University

Dates:
Date Received: January 31, 2006
Date Started: August 2006
Date Completion:
Last Updated: February 16, 2015
Last Verified: February 2015