Erlotinib for Treatment of Psoriasis

Sponsor

Northwestern University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01006096

Collaborator

OSI Pharmaceuticals (Industry)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: erlotinib Other: placebo tablet	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erlotinib	Drug: erlotinib 100mg tablet, once daily for 16 weeks Other Names: Tarceva
Placebo Comparator: Placebo tablets	Other: placebo tablet placebo tablet (lactose), once daily for 16 weeks

Arm

Intervention/Treatment

Experimental: Erlotinib

Drug: erlotinib

100mg tablet, once daily for 16 weeks

Other Names:

Tarceva

Placebo Comparator: Placebo tablets

Other: placebo tablet

placebo tablet (lactose), once daily for 16 weeks

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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