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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563524
• Other study ID #: 3199K2-1105
• Secondary ID: B1981002
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2007
• Last updated: March 9, 2011
• Start date: December 2007
• Est. completion date: June 2010

Study information

• Verified date: March 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• ILV-094
SC and IV administration on days 1, 14, 28, and 42

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Waterloo	Ontario
Hong Kong	Pfizer Investigational Site	Pokfulam
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	George	Western Cape
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fort Gratiot	Michigan
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Lenexa	Kansas
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety, and tolerability of ascending multiple subcutaneous (SC) or intravenous (IV) doses of ILV-094 administered to subjects with psoriasis.		126 days	Yes
Primary	Psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks.		56 to 84 days	No
Secondary	pharmacokinetic (PK), pharmacodynamics (PD), and immunogenicity of multiple ascending SC or IV doses of ILV-094 administered to subjects with psoriasis.		126 days	No

External Links

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