Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis - Full Text View

Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This study is ongoing, but not recruiting participants.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00292396

Purpose

The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis

Condition	Intervention	Phase
Psoriasis	Drug: Anti IL-12 monoclonal antibody/ABT-874/up to 12 weeks	Phase II

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Interleukin-12

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects with clinical response relative to Baseline PASI score

Secondary Outcome Measures:

QOLs
Clinical response indicators
Safety parameters

Enrollment:	180
Study Start Date:	February 2006

Eligibility

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

Criteria

Inclusion Criteria:

Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion Criteria:

Subject had previously received systemic or biologic anti-IL-12 therapy
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
Subject is taking or requires oral or injectable corticosteroids
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292396

Locations


United States, Illinois
	Global Medical Information - Abbott
	Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Beverly Paperiello	Abbott

More Information

Publications indexed to this study:

Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7.

Study ID Numbers:	M05-736
First Received:	February 14, 2006
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00292396
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Interleukin-12

Skin Diseases

Psoriasis

Connective Tissue Diseases

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin and Connective Tissue Diseases

Immunologic Factors

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on May 15, 2008