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

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 Drug: placebo	Phase II

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Interleukin-12

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), 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 [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life Surveys [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: Yes ]
Clinical response indicators [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: Monthly through duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	180
Study Start Date:	November 2005
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks	Drug: Anti IL-12 monoclonal antibody/ABT-874 Please see Arm Description for intervention description and details.
2: Active Comparator Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks	Drug: Anti IL-12 monoclonal antibody/ABT-874 Please see Arm Description for intervention description and details.
3: Active Comparator Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks	Drug: Anti IL-12 monoclonal antibody/ABT-874 Please see Arm Description for intervention description and details.
4: Active Comparator Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks	Drug: Anti IL-12 monoclonal antibody/ABT-874 Please see Arm Description for intervention description and details.
5: Active Comparator Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks	Drug: Anti IL-12 monoclonal antibody/ABT-874 Please see Arm Description for intervention description and details.
6: Placebo Comparator placebo, 12 doses	Drug: placebo 12 doses

Eligibility

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:

Responsible Party:	Abbott ( Nicky Mayber )
Study ID Numbers:	M05-736
First Received:	February 14, 2006
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00292396
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Interleukin-12

Psoriasis

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Immunologic Factors

Skin Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

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