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

NCT00563524

Last updated date
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90211, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
 (submitted: March 9, 2011)
76
Original Enrollment  ICMJE
 (submitted: November 23, 2007)
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:

  • 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.)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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