Open Label Continuation Study in Moderate to Severe Psoriasis

January 28, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2301

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

  • Austria
      • Graz, Austria, 8036
        • Site Reference ID/Investigator# 16845
      • Vienna, Austria, 1090
        • Site Reference ID/Investigator# 18183
  • Belgium
      • Brussels, Belgium, 1200
        • Site Reference ID/Investigator# 15761
  • Canada
      • Barrie, Canada, L4M 6L2
        • Site Reference ID/Investigator# 7991
      • Calgary, Canada, T3G 0B4
        • Site Reference ID/Investigator# 8047
      • Edmonton, Canada, T5K 1X3
        • Site Reference ID/Investigator# 7996
      • Halifax, Canada, B3H 0A2
        • Site Reference ID/Investigator# 6996
      • Hamilton, Canada, L8N 1V6
        • Site Reference ID/Investigator# 7236
      • Laval, Canada, H7S 2C6
        • Site Reference ID/Investigator# 6995
      • London, Canada, N5X 2P1
        • Site Reference ID/Investigator# 6998
      • London, Canada, N6A 3H7
        • Site Reference ID/Investigator# 7043
      • Markham, Canada, L3P 1A8
        • Site Reference ID/Investigator# 7329
      • Montreal, Canada, H2K 4L5
        • Site Reference ID/Investigator# 6999
      • Montreal, Canada, H3H 1V4
        • Site Reference ID/Investigator# 7652
      • North Bay, Canada, P1B 3Z7
        • Site Reference ID/Investigator# 7006
      • Ottawa, Canada, K2G 6E2
        • Site Reference ID/Investigator# 8102
      • Quebec City, Canada, G1V 4X7
        • Site Reference ID/Investigator# 6993
      • St. John's, Canada, A1A 5E8
        • Site Reference ID/Investigator# 8112
      • Surrey, Canada, V3R 6A7
        • Site Reference ID/Investigator# 7931
      • Vancouver, Canada, V5Z 3Y1
        • Site Reference ID/Investigator# 8118
      • Vancouver, Canada, V5Z 4E8
        • Site Reference ID/Investigator# 6997
      • Waterloo, Canada, N2J 1C4
        • Site Reference ID/Investigator# 6994
      • Westmount, Canada, H3Z 2S6
        • Site Reference ID/Investigator# 8111
      • Windsor, Canada, N8W 1E6
        • Site Reference ID/Investigator# 7005
      • Windsor, Canada, N8W 5L7
        • Site Reference ID/Investigator# 7979
      • Winnipeg, Canada, R3C 1R4
        • Site Reference ID/Investigator# 8348
  • Denmark
      • Aarhus, Denmark, 8000
        • Site Reference ID/Investigator# 17781
      • Copenhagen NV, Denmark, 2400
        • Site Reference ID/Investigator# 18041
  • Finland
      • Helsinki, Finland, 00029 HUS
        • Site Reference ID/Investigator# 18661
      • Kuopio, Finland, 70210
        • Site Reference ID/Investigator# 18701
      • Lahti, Finland, 15850
        • Site Reference ID/Investigator# 14962
      • Turku, Finland, 20521
        • Site Reference ID/Investigator# 19241
  • France
      • Nice, France, 06200
        • Site Reference ID/Investigator# 18502
      • Paris Cedex 10, France, 75475
        • Site Reference ID/Investigator# 16781
      • Toulouse, Cedex 9, France, 31059
        • Site Reference ID/Investigator# 18506
  • Germany
      • Berlin, Germany, 10117
        • Site Reference ID/Investigator# 16281
      • Frankfurt am Main, Germany, 60590
        • Site Reference ID/Investigator# 15664
      • Hamburg, Germany, D-20354
        • Site Reference ID/Investigator# 15663
      • Kiel, Germany, 24105
        • Site Reference ID/Investigator# 16381
      • Muenster, Germany, 48149
        • Site Reference ID/Investigator# 16161
      • Munich, Germany, D-80337
        • Site Reference ID/Investigator# 16143
      • Tuebingen, Germany, 72076
        • Site Reference ID/Investigator# 17676
  • Greece
      • Athens, Greece, 161 21
        • Site Reference ID/Investigator# 16282
      • Athens, Greece, 16121
        • Site Reference ID/Investigator# 15921
      • Thessaloniki, Greece, 54643
        • Site Reference ID/Investigator# 15922
  • Italy
      • Modena, Italy, 41100
        • Site Reference ID/Investigator# 15401
      • Rome, Italy, 00133
        • Site Reference ID/Investigator# 14881
  • Spain
      • Barcelona, Spain, 08916
        • Site Reference ID/Investigator# 19322
      • Madrid, Spain, 28006
        • Site Reference ID/Investigator# 15341
  • Sweden
      • Stockholm, Sweden, 171 76
        • Site Reference ID/Investigator# 16142
  • Switzerland
      • Geneva 14, Switzerland, 1211
        • Site Reference ID/Investigator# 17721
      • Zurich, Switzerland, 8091
        • Site Reference ID/Investigator# 16749
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZR
        • Site Reference ID/Investigator# 19045
      • Manchester, United Kingdom, M6 8HD
        • Site Reference ID/Investigator# 15422
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Site Reference ID/Investigator# 7496
      • Birmingham, Alabama, United States, 35233
        • Site Reference ID/Investigator# 8438
      • Huntsville, Alabama, United States, 35801
        • Site Reference ID/Investigator# 7522
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Site Reference ID/Investigator# 7774
      • Tucson, Arizona, United States, 85710
        • Site Reference ID/Investigator# 7435
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Site Reference ID/Investigator# 7933
    • California
      • Bakersfield, California, United States, 93309
        • Site Reference ID/Investigator# 7234
      • Fresno, California, United States, 93720
        • Site Reference ID/Investigator# 8249
      • Irvine, California, United States, 92697
        • Site Reference ID/Investigator# 7332
      • Los Angeles, California, United States, 90045
        • Site Reference ID/Investigator# 7239
      • Oceanside, California, United States, 92056
        • Site Reference ID/Investigator# 8390
      • San Diego, California, United States, 92103
        • Site Reference ID/Investigator# 7503
      • San Diego, California, United States, 92117
        • Site Reference ID/Investigator# 7520
      • San Diego, California, United States, 92123
        • Site Reference ID/Investigator# 7010
      • San Francisco, California, United States, 94118
        • Site Reference ID/Investigator# 10962
      • Santa Monica, California, United States, 90404
        • Site Reference ID/Investigator# 7334
      • Vallejo, California, United States, 94589
        • Site Reference ID/Investigator# 7793
    • Colorado
      • Denver, Colorado, United States, 80209
        • Site Reference ID/Investigator# 7929
      • Longmont, Colorado, United States, 80501
        • Site Reference ID/Investigator# 7436
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Site Reference ID/Investigator# 7521
    • Florida
      • Doral, Florida, United States, 33166-6665
        • Site Reference ID/Investigator# 7653
      • Jacksonville, Florida, United States, 32204
        • Site Reference ID/Investigator# 8341
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 7716
      • Miami, Florida, United States, 33144
        • Site Reference ID/Investigator# 7657
      • South Miami, Florida, United States, 33143
        • Site Reference ID/Investigator# 10841
      • West Palm Beach, Florida, United States, 33409-3509
        • Site Reference ID/Investigator# 7893
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Site Reference ID/Investigator# 7331
      • Atlanta, Georgia, United States, 30327
        • Site Reference ID/Investigator# 9743
      • Newnan, Georgia, United States, 30263
        • Site Reference ID/Investigator# 7891
      • Snellville, Georgia, United States, 30078
        • Site Reference ID/Investigator# 7932
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Site Reference ID/Investigator# 8379
      • Maywood, Illinois, United States, 60153
        • Site Reference ID/Investigator# 8798
      • Schaumburg, Illinois, United States, 60194
        • Site Reference ID/Investigator# 10703
      • Skokie, Illinois, United States, 60077
        • Site Reference ID/Investigator# 6950
      • West Dundee, Illinois, United States, 60118
        • Site Reference ID/Investigator# 7892
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Site Reference ID/Investigator# 6933
      • Indianapolis, Indiana, United States, 46260
        • Site Reference ID/Investigator# 10422
      • Plainfield, Indiana, United States, 46168
        • Site Reference ID/Investigator# 16581
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Site Reference ID/Investigator# 7992
    • Kentucky
      • Henderson, Kentucky, United States, 42420
        • Site Reference ID/Investigator# 17193
      • Louisville, Kentucky, United States, 40202
        • Site Reference ID/Investigator# 8528
      • Owensboro, Kentucky, United States, 42303
        • Site Reference ID/Investigator# 9962
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Site Reference ID/Investigator# 8529
      • Boston, Massachusetts, United States, 02111
        • Site Reference ID/Investigator# 8149
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Site Reference ID/Investigator# 9823
      • Fort Gratiot, Michigan, United States, 48059
        • Site Reference ID/Investigator# 7883
      • Grand Blanc, Michigan, United States, 48439
        • Site Reference ID/Investigator# 7238
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Site Reference ID/Investigator# 7656
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 6930
      • St. Louis, Missouri, United States, 63117
        • Site Reference ID/Investigator# 6949
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 7240
      • Omaha, Nebraska, United States, 68144
        • Site Reference ID/Investigator# 9567
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Site Reference ID/Investigator# 7757
      • East Windsor, New Jersey, United States, 08520
        • Site Reference ID/Investigator# 7330
      • New Brunswick, New Jersey, United States, 08903
        • Site Reference ID/Investigator# 7882
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Site Reference ID/Investigator# 7455
    • New York
      • Buffalo, New York, United States, 14221
        • Site Reference ID/Investigator# 8078
      • New York, New York, United States, 10016
        • Site Reference ID/Investigator# 8392
      • New York, New York, United States, 10025
        • Site Reference ID/Investigator# 8006
      • New York, New York, United States, 10029-6501
        • Site Reference ID/Investigator# 7230
      • New York, New York, United States, 10032
        • Site Reference ID/Investigator# 10201
      • Rochester, New York, United States, 14623
        • Site Reference ID/Investigator# 8037
      • Stoney Brook, New York, United States, 11790
        • Site Reference ID/Investigator# 7333
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Site Reference ID/Investigator# 7434
      • Wilmington, North Carolina, United States, 28401
        • Site Reference ID/Investigator# 8117
      • Winston-Salem, North Carolina, United States, 27157
        • Site Reference ID/Investigator# 9681
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 6945
      • Cincinnati, Ohio, United States, 45220
        • Site Reference ID/Investigator# 23345
      • Cleveland, Ohio, United States, 44106
        • Site Reference ID/Investigator# 7044
      • Columbus, Ohio, United States, 43212
        • Site Reference ID/Investigator# 7899
      • Dayton, Ohio, United States, 45408
        • Site Reference ID/Investigator# 8389
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Site Reference ID/Investigator# 11181
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Site Reference ID/Investigator# 6936
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 7703
      • Portland, Oregon, United States, 97223
        • Site Reference ID/Investigator# 6948
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 11424
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Site Reference ID/Investigator# 8494
      • Philadelphia, Pennsylvania, United States, 19103
        • Site Reference ID/Investigator# 7930
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Site Reference ID/Investigator# 6934
      • Providence, Rhode Island, United States, 02903
        • Site Reference ID/Investigator# 6935
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Site Reference ID/Investigator# 7785
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Site Reference ID/Investigator# 7497
      • Knoxville, Tennessee, United States, 37934
        • Site Reference ID/Investigator# 7388
      • Nashville, Tennessee, United States, 37215
        • Site Reference ID/Investigator# 6931
    • Texas
      • Arlington, Texas, United States, 76011
        • Site Reference ID/Investigator# 7684
      • Austin, Texas, United States, 78759
        • Site Reference ID/Investigator# 10842
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 7498
      • Dallas, Texas, United States, 75246-1613
        • Site Reference ID/Investigator# 6947
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 6944
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7758
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 8108
      • Tyler, Texas, United States, 75703
        • Site Reference ID/Investigator# 6937
      • Webster, Texas, United States, 77598
        • Site Reference ID/Investigator# 7655
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Site Reference ID/Investigator# 10207
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Site Reference ID/Investigator# 6946
    • Washington
      • Seattle, Washington, United States, 98101
        • Site Reference ID/Investigator# 6932
      • Spokane, Washington, United States, 99204
        • Site Reference ID/Investigator# 10306
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Site Reference ID/Investigator# 7884

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:

  • Having participated in a preceding ABT-874 clinical trial for ABT-874
  • Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Exclusion Criteria:

  • Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-874
100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks
Other Names:
  • briakinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.
Time Frame: Visit (12 weeks)
Visit (12 weeks)
Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
Time Frame: Visit (12 weeks)
Visit (12 weeks)
Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
Time Frame: Visit (12 weeks)
Visit (12 weeks)
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study
Time Frame: Visit (12 weeks)
Visit (12 weeks)

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

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

February 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-016
  • 2007-005955-40 (EudraCT Number)

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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