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

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: ILV-094	Phase I

MedlinePlus related topics:

Psoriasis

U.S. FDA Resources

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

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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	6
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: ILV-094 Each subject receives ILV-094 or Placebo every 2 weeks for a total of 4 administations

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563524

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


United States, Indiana
		Recruiting
	Indianapolis, Indiana, United States, 46256

United States, Massachusetts
		Not yet recruiting
	Boston, Massachusetts, United States

United States, Missouri
		Recruiting
	St. Louis, Missouri, United States, 63117

United States, New York
		Not yet recruiting
	New York, New York, United States, 10028

United States, Pennsylvania
		Not yet recruiting
	Duncansville, Pennsylvania, United States, 16635

United States, Texas
		Not yet recruiting
	Dallas, Texas, United States, 75246

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3199K2-1105
First Received:	November 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00563524
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00563524