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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Interleukin-12

U.S. FDA Resources

Further study details as provided by AbbVie:

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

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

Arms	Assigned Interventions
Active Comparator: 1 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.
Active Comparator: 2 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.
Active Comparator: 3 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.
Active Comparator: 4 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.
Active Comparator: 5 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.
Placebo Comparator: 6 placebo, 12 doses	Drug: placebo 12 doses

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

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Locations

United States, California
Site Reference ID/Investigator# 3351
San Diego, California, United States, 92123
United States, Georgia
Site Reference ID/Investigator# 3347
Alpharetta, Georgia, United States, 30022
United States, Illinois
Site Reference ID/Investigator# 3348
Skokie, Illinois, United States, 60077
United States, Indiana
Site Reference ID/Investigator# 993
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Site Reference ID/Investigator# 990
Boston, Massachusetts, United States, 02114
United States, Missouri
Site Reference ID/Investigator# 3349
St. Louis, Missouri, United States, 63117
United States, Ohio
Site Reference ID/Investigator# 992
Cincinnati, Ohio, United States, 45219
United States, Oregon
Site Reference ID/Investigator# 991
Lake Oswego, Oregon, United States, 97035
Site Reference ID/Investigator# 3367
Portland, Oregon, United States, 97223
United States, Rhode Island
Site Reference ID/Investigator# 3346
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Site Reference ID/Investigator# 994
Nashville, Tennessee, United States, 37215
United States, Texas
Site Reference ID/Investigator# 3350
Dallas, Texas, United States, 75246-1613
Site Reference ID/Investigator# 796
Houston, Texas, United States, 77030
United States, Utah
Site Reference ID/Investigator# 2081
Salt Lake City, Utah, United States, 84132
United States, Virginia
Site Reference ID/Investigator# 3366
Norfolk, Virginia, United States, 23507
United States, Washington
Site Reference ID/Investigator# 989
Seattle, Washington, United States, 98101
Canada
Site Reference ID/Investigator# 3361
Halifax, Canada, B3H 1Z4
Site Reference ID/Investigator# 985
Laval, Canada, H7S 2C6
Site Reference ID/Investigator# 987
London, Canada, N5X 2P1
Site Reference ID/Investigator# 3364
Montreal, Canada, H2K 4L5
Site Reference ID/Investigator# 794
North Bay, Canada, P1B 3Z7
Site Reference ID/Investigator# 988
Quebec City, Canada, G1V 4X7
Site Reference ID/Investigator# 795
Waterloo, Canada, N2J 1C4
Site Reference ID/Investigator# 3360
Windsor, Canada, N8W 1E6

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Chair:

Martin Kaul, MD

AbbVie

More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00292396 History of Changes
Other Study ID Numbers:	M05-736
Study First Received:	February 14, 2006
Last Updated:	January 10, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies

Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013