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

January 10, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with clinical response relative to Baseline PASI score
Time Frame: Week 12, Week 40 and Week 60
Week 12, Week 40 and Week 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Surveys
Time Frame: Week 12, Week 48 and Week 60
Week 12, Week 48 and Week 60
Clinical response indicators
Time Frame: Week 12, Week 48 and Week 60
Week 12, Week 48 and Week 60
Safety parameters
Time Frame: Monthly through duration of study
Monthly through duration of study
PGA Assessment
Time Frame: Week 12, Week 40 and Week 60
Week 12, Week 40 and Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Chair: Martin Kaul, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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