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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT00292396

First received: February 14, 2006

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2006

Last Updated Date

January 10, 2013

Start Date ^ICMJE

November 2005

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Proportion of subjects with clinical response relative to Baseline PASI score

Change History

Complete list of historical versions of study NCT00292396 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
PGA Assessment [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

QOLs, clinical response indicators, safety parameters

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 2, Multi-Center, 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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
Drug: placebo
12 doses

Study Arm (s)

Active Comparator: 1
Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks

Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
Active Comparator: 2
Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks

Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
Active Comparator: 3
Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks

Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
Active Comparator: 4
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks

Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
Active Comparator: 5
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks

Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
Placebo Comparator: 6
placebo, 12 doses

Intervention: Drug: placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00292396

Other Study ID Numbers ^ICMJE

M05-736

Has Data Monitoring Committee

Yes

Responsible Party

AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Sponsor ^ICMJE

AbbVie (prior sponsor, Abbott)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Martin Kaul, MD

AbbVie

Information Provided By

AbbVie

Verification Date

January 2013

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

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