Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis

AN ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL EFFICACY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY OR INTRAVENOUSLY TO SUBJECTS WITH PSORIASIS

The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis

Inclusion Criteria:

• Men and Women of nonchildbearing potential 18 years or older.
• Physician Area and Severity Index (PASI) greater than 11.
• Physician Global Assessment (PGA) greater than 3.

Exclusion Criteria:

• Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.
• Live vaccines within 3 months before test article administration or during the study.
• Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.
• Psoralen plus ultraviolet A radiation (PUVA) therapy within 4 weeks before study day 1.
• Ultraviolet B (UVB) therapy within 2 weeks before study day 1.
• Receipt of systemic psoriasis therapy (eg, oral retinoids, methotrexate, hydroxyurea, cyclosporine, or azathioprine) or systemic corticosteroids within 4 weeks before study day 1.
• Topical steroids, topical vitamin A or D analog preparations, or anthralin within 2 weeks before study day 1. (Exception: topical therapies, including steroids at no higher than mild strength [class 6 or 7 topical corticosteroids], are permitted on the scalp, axillae, face, and groin, but the dose of the medication must be kept stable throughout the trial.)