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
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: ILV-094
Phase 1

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 76
Study Start Date: December 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: ILV-094
SC and IV administration on days 1, 14, 28, and 42
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563524

  Show 22 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00563524     History of Changes
Other Study ID Numbers: 3199K2-1105, B1981002
Study First Received: November 21, 2007
Last Updated: March 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014