Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563524
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| 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, T6G 2B7 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T5K 1X3 | |
| 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
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 May 16, 2013