Erlotinib for Treatment of Psoriasis

Northwestern University

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Psoriasis

Interventions

erlotinibDRUG

100mg tablet, once daily for 16 weeks

placebo tabletOTHER

placebo tablet (lactose), once daily for 16 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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).

Time frame: week 4, 8, 12, 16, and 24

Secondary Outcomes

To determine the rate of dose reduction or interruption as a result of adverse events.

Time frame: week 4, 8, 12, 16, and 24

To determine quality of life using the Dermatology Life Quality Index (DLQI).

Time frame: week 4, 8, 12, 16, and 24

Data from ClinicalTrials.gov

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