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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00563524
First received: November 21, 2007
Last updated: March 9, 2011
Last verified: March 2011
History of Changes

November 21, 2007
March 9, 2011
December 2007
June 2010   (final data collection date for primary outcome measure)
  • To assess the safety, and tolerability of ascending multiple subcutaneous (SC) or intravenous (IV) doses of ILV-094 administered to subjects with psoriasis. [ Time Frame: 126 days ] [ Designated as safety issue: Yes ]
  • Psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks. [ Time Frame: 56 to 84 days ] [ Designated as safety issue: No ]
Psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks. [ Time Frame: 4 Months ]
Complete list of historical versions of study NCT00563524 on ClinicalTrials.gov Archive Site
pharmacokinetic (PK), pharmacodynamics (PD), and immunogenicity of multiple ascending SC or IV doses of ILV-094 administered to subjects with psoriasis. [ Time Frame: 126 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
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

The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
Drug: ILV-094
SC and IV administration on days 1, 14, 28, and 42
Other Name: placebo
Placebo Comparator: 1
Intervention: Drug: ILV-094
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
June 2010
June 2010   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Hong Kong,   South Africa
 
NCT00563524
3199K2-1105, B1981002
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP