Study Evaluating the Safety and Tolerability of ILV-094 in Subjects With Psoriasis - Tabular View

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Study Evaluating the Safety and Tolerability of ILV-094 in Subjects With Psoriasis

This study is not yet open for participant recruitment.

Study NCT00563524. Last updated on December 21, 2007. Information provided by Wyeth

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Study Evaluating the Safety and Tolerability of ILV-094 in Subjects With Psoriasis

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

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

To evaluate the clinical effect of ILV-094 on psoriasis activity as defined by change in the psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Condition ^†

Psoriasis

Intervention ^†

Drug: ILV-094

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Start Date ^†

January 2008

Completion Date

September 2008

Eligibility Criteria ^†

Inclusion Criteria:

Men 18 years or older.
Physician Area and Severity Index (PASI) greater than 11
Physician Global Assessment (PGA) greater than 3

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00563524

Organization ID

3199K2-1105

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

December 2007

First Received Date ^†

November 21, 2007

Last Updated Date

December 21, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.