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

Completed · Phase 1 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT00563524

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

76

Starts

2007-12-20

Expected to finish

2010-06-14

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• David Stoll, MD — Beverly Hills, California, United States
• Dermatology Research — Santa Monica, California, United States
• Miami Research Associates — South Miami, Florida, United States
• MRA Clinical Research — South Miami, Florida, United States
• Hudson Dermatology — Evansville, Indiana, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• Dawes Fretzin Dermatology Group — Indianapolis, Indiana, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Central Dermatology — St Louis, Missouri, United States
• New York University Medical Center — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Duke Clinical Reseach Unit — Durham, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Baylor Research Institute — Dallas, Texas, United States
• Stratical Medical — Edmonton, Alberta, Canada
• University of Alberta, Hospital Site Clinical Sciences Building — Edmonton, Alberta, Canada
• The Northern Alberta Clinical Trials and Research Centre (NACTRC) — Edmonton, Alberta, Canada
• Bio Pharma Services Inc — Toronto, Ontario, Canada
• K. Papp Clinical Research — Waterloo, Ontario, Canada
• Innovaderm Recherches Inc — Montreal, Quebec, Canada
• Queen Mary Hospital — Hong Kong, Hong Kong
• FARMOVS Parexel (Pty) Ltd — Bloemfontein, Free State, South Africa
• Parexel George — George, Western Cape, South Africa

Full record on ClinicalTrials.gov

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