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

NCT ID: NCT00563524

Last Updated: 2024-08-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-20

Study Completion Date

2010-06-14

Brief Summary

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The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

ILV-094

Intervention Type DRUG

SC and IV administration on days 1, 14, 28, and 42

Interventions

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ILV-094

SC and IV administration on days 1, 14, 28, and 42

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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David Stoll, MD

Beverly Hills, California, United States

Site Status

Dermatology Research

Santa Monica, California, United States

Site Status

Miami Research Associates

South Miami, Florida, United States

Site Status

MRA Clinical Research

South Miami, Florida, United States

Site Status

Hudson Dermatology

Evansville, Indiana, United States

Site Status

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Site Status

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Central Dermatology

St Louis, Missouri, United States

Site Status

New York University Medical Center

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Duke Clinical Reseach Unit

Durham, North Carolina, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

Stratical Medical

Edmonton, Alberta, Canada

Site Status

University of Alberta, Hospital Site Clinical Sciences Building

Edmonton, Alberta, Canada

Site Status

The Northern Alberta Clinical Trials and Research Centre (NACTRC)

Edmonton, Alberta, Canada

Site Status

Bio Pharma Services Inc

Toronto, Ontario, Canada

Site Status

K. Papp Clinical Research

Waterloo, Ontario, Canada

Site Status

Innovaderm Recherches Inc

Montreal, Quebec, Canada

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

FARMOVS Parexel (Pty) Ltd

Bloemfontein, Free State, South Africa

Site Status

Parexel George

George, Western Cape, South Africa

Site Status

Countries

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United States Canada Hong Kong South Africa

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=3199K2-1105

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1981002

Identifier Type: OTHER

Identifier Source: secondary_id

2009-012554-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3199K2-1105

Identifier Type: -

Identifier Source: org_study_id

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