We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00563524
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : March 10, 2011
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: ILV-094 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: 1 Drug: ILV-094
SC and IV administration on days 1, 14, 28, and 42
Other Name: placebo

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563524

Layout table for location information
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33173
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47714
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46256
United States, Kansas
Pfizer Investigational Site
Lenexa, Kansas, United States, 66219
United States, Michigan
Pfizer Investigational Site
Fort Gratiot, Michigan, United States, 48059
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63117
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10016
Pfizer Investigational Site
New York, New York, United States, 10029
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246-1613
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5K 1X3
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M9L 3A2
Pfizer Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Hong Kong
Pfizer Investigational Site
Pokfulam, Hong Kong
South Africa
Pfizer Investigational Site
Bloemfontein, Free State, South Africa, 9301
Pfizer Investigational Site
George, Western Cape, South Africa, 6529
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00563524    
Other Study ID Numbers: 3199K2-1105
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents