Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

January 11, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Phase 3

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

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Site Reference ID/Investigator# 8478
    • California
      • Fresno, California, United States, 93720
        • Site Reference ID/Investigator# 8462
      • Los Angeles, California, United States, 90045
        • Site Reference ID/Investigator# 8454
    • Colorado
      • Denver, Colorado, United States, 80209
        • Site Reference ID/Investigator# 8476
    • Florida
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 9641
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Site Reference ID/Investigator# 8463
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Site Reference ID/Investigator# 8479
      • Schaumburg, Illinois, United States, 60194
        • Site Reference ID/Investigator# 8527
      • Skokie, Illinois, United States, 60077
        • Site Reference ID/Investigator# 9001
      • West Dundee, Illinois, United States, 60118
        • Site Reference ID/Investigator# 8466
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Site Reference ID/Investigator# 8467
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Site Reference ID/Investigator# 8464
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Site Reference ID/Investigator# 8459
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Site Reference ID/Investigator# 8473
      • New Brunswick, New Jersey, United States, 08903
        • Site Reference ID/Investigator# 8457
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Site Reference ID/Investigator# 8447
    • New York
      • New York, New York, United States, 10029-6501
        • Site Reference ID/Investigator# 8475
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 8468
      • Cleveland, Ohio, United States, 44106
        • Site Reference ID/Investigator# 8460
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Site Reference ID/Investigator# 9762
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Site Reference ID/Investigator# 8480
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 8469
      • Portland, Oregon, United States, 97223
        • Site Reference ID/Investigator# 9566
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Site Reference ID/Investigator# 9761
      • Philadelphia, Pennsylvania, United States, 19103
        • Site Reference ID/Investigator# 8471
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Site Reference ID/Investigator# 8449
      • Providence, Rhode Island, United States, 02903
        • Site Reference ID/Investigator# 8448
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Site Reference ID/Investigator# 8456
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Site Reference ID/Investigator# 8458
    • Texas
      • Austin, Texas, United States, 78759
        • Site Reference ID/Investigator# 8461
      • Dallas, Texas, United States, 75246-1613
        • Site Reference ID/Investigator# 10542
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 8452
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 8474
      • Tyler, Texas, United States, 75703
        • Site Reference ID/Investigator# 8482
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Site Reference ID/Investigator# 8472

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:

  • Diagnosis of Psoriasis for 6 mo.
  • BSA 10%, PASI 12 or above, PGA 3 or above

Exclusion Criteria:

  • Previous exposure to either etanercept or ABT-874

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: B
Biological: etanercept
SQ injection 50 mg BIW
Placebo Comparator: C
Drug: placebo
SQ placebo injections for ABT-874 and etanercept
Experimental: A
Biological: ABT-874
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Time Frame: 12 Weeks
12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Paragon Biomedical

Investigators

  • Study Director: 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

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-114

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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