Erlotinib for Treatment of Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.

Detailed Description
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Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.

Official Title
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Phase II Randomized, Double-blind, Placebo-controlled, Two-arm Study to Evaluate the Safety and Efficacy of Erlotinib in the Treatment of Moderate to Severe Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: erlotinib
* Other: placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of moderate to severe psoriasis Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI) Must be able to swallow tablets Must be able to provide written informed consent Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization. Exclusion Criteria: Use of concurrent agents/therapies for psoriasis Bilirubin > 3 X ≥ ULN or moderate to severe hepatic impairment Pregnant or breast-feeding females Subjects currently receiving other anticancer treatments Subjects currently receiving other biologic treatments Subjects currently receiving blood thinners (warfarin or heparin) Subjects who currently smoke Subjects with other skin disease which in the opinion of the investigator, would inhibit the ability to use the PGA and PASI evaluation methods

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br> | Drug: erlotinib<br>* 100mg tablet, once daily for 16 weeks<br>* Other names: Tarceva;|
| Placebo Comparator: Placebo tablets<br> | Other: placebo tablet<br>* placebo tablet (lactose), once daily for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA). |  | week 4, 8, 12, 16, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of dose reduction or interruption as a result of adverse events. |  | week 4, 8, 12, 16, and 24 | 
| To determine quality of life using the Dermatology Life Quality Index (DLQI). |  | week 4, 8, 12, 16, and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, double-blind, randomized, placebo-controlled, erlotinib, efficacy