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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: ILV-094

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563524

3199K2-1105

B1981002

2009-012554-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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76 participants in 1 patient group, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: ILV-094