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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90211 United States
Contact
1-800-718-1021
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.)

NCT00563524
Pfizer
Completed
Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis

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Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
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
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
Drug: ILV-094
SC and IV administration on days 1, 14, 28, and 42
Other Name: placebo
Placebo Comparator: 1
Intervention: Drug: ILV-094
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Hong Kong,   South Africa,   United States
 
 
NCT00563524
3199K2-1105
B1981002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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