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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
Sponsor:
Information provided by:

Study Description
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

Study Design

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
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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


  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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00563524     History of Changes
Other Study ID Numbers: 3199K2-1105
B1981002
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

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