Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Drug: ILV-094 | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Drug: ILV-094
SC and IV administration on days 1, 14, 28, and 42
Other Name: placebo |
- 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 ]
- 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 ]
- 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 ]

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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.)

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
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
ClinicalTrials.gov Identifier: | NCT00563524 |
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 |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Fezakinumab Dermatologic Agents |