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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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