Erlotinib for Treatment of Psoriasis

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride

Criteria

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