- 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.
- 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
- 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
- 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.)