Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
NCT00563524
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.)
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Psoriasis | |||
Intervention ICMJE | Drug: ILV-094
SC and IV administration on days 1, 14, 28, and 42 Other Name: placebo | |||
Study Arms ICMJE | Placebo Comparator: 1
Intervention: Drug: ILV-094 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 76 | |||
Original Enrollment ICMJE | 72 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Hong Kong, South Africa, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00563524 | |||
Other Study ID Numbers ICMJE | 3199K2-1105 B1981002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |