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

CompletedPhase 1

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Conditions: Psoriasis

Interventions: ILV-094

Countries: United States, Canada, Hong Kong, South Africa

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.)

Locations (24)

Beverly Hills, California, United States
Santa Monica, California, United States
South Miami, Florida, United States
South Miami, Florida, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Fort Gratiot, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Duncansville, Pennsylvania, United States
Dallas, Texas, United States
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Montreal, Quebec, Canada
Hong Kong, Hong Kong
Bloemfontein, Free State, South Africa
George, Western Cape, South Africa