Psoriasis
Conditions
Keywords
Psoriasis, double-blind, randomized, placebo-controlled, erlotinib, efficacy
Brief summary
The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.
Detailed description
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.
Interventions
DRUGerlotinib
100mg tablet, once daily for 16 weeks
OTHERplacebo tablet
placebo tablet (lactose), once daily for 16 weeks
Sponsors
OSI Pharmaceuticals
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed