Erlotinib for Treatment of Psoriasis

Northwestern University

Status and phase: Withdrawn; Phase 2

Conditions: Psoriasis

Treatments: Other: placebo tablet; Drug: erlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01006096

MEL-041509

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Erlotinib

Experimental group

Treatment:

Drug: erlotinib

Placebo tablets

Placebo Comparator group

Treatment:

Other: placebo tablet