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

Tracking Information

First Received Date ^ICMJE

November 21, 2007

Last Updated Date

August 18, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Psoriasis area and severity index score, target lesion score, and the physician global assessment of psoriasis score at 6 and 8 weeks. [ Time Frame: 4 Months ]

Change History

Complete list of historical versions of study NCT00563524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: ILV-094

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2010

Estimated Primary Completion Date

December 2009 (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^ICMJE

United States, Canada, Hong Kong

Administrative Information

NCT ID ^ICMJE

NCT00563524

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

3199K2-1105

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP