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

February 6, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1465

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

  • Canada
      • Barrie, Canada, L4M 6L2
        • Site Reference ID/Investigator# 7314
      • Calgary, Canada, T3A 2N1
        • Site Reference ID/Investigator# 7452
      • Edmonton, Canada, T5K 1X3
        • Site Reference ID/Investigator# 6702
      • Halifax, Canada, B3H 0A2
        • Site Reference ID/Investigator# 6716
      • Hamilton, Canada, L8N 1V6
        • Site Reference ID/Investigator# 7309
      • Laval, Canada, H7S 2C6
        • Site Reference ID/Investigator# 6588
      • London, Canada, N5X 2P1
        • Site Reference ID/Investigator# 6715
      • London, Canada, N6A 3H7
        • Site Reference ID/Investigator# 7315
      • Markham, Canada, L3P 1A8
        • Site Reference ID/Investigator# 7636
      • Montreal, Canada, H2K 4L5
        • Site Reference ID/Investigator# 6699
      • Montreal, Canada, H3H 1V4
        • Site Reference ID/Investigator# 7316
      • North Bay, Canada, P1B 3Z7
        • Site Reference ID/Investigator# 7088
      • Ottawa, Canada, K2G 6E2
        • Site Reference ID/Investigator# 7310
      • Quebec City, Canada, G1V 4X7
        • Site Reference ID/Investigator# 7311
      • St. John's, Canada, A1A 5E8
        • Site Reference ID/Investigator# 7313
      • Surrey, Canada, V3R 6A7
        • Site Reference ID/Investigator# 7317
      • Vancouver, Canada, V5Z 3Y1
        • Site Reference ID/Investigator# 7308
      • Vancouver, Canada, V5Z 4E8
        • Site Reference ID/Investigator# 6713
      • Waterloo, Canada, N2J 1C4
        • Site Reference ID/Investigator# 7067
      • Westmount, Canada, H3Z 2S6
        • Site Reference ID/Investigator# 7312
      • Windsor, Canada, N8W 1E6
        • Site Reference ID/Investigator# 7087
      • Windsor, Canada, N8W 5L7
        • Site Reference ID/Investigator# 6805
      • Winnipeg, Canada, R3C 1R4
        • Site Reference ID/Investigator# 7638
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Site Reference ID/Investigator# 6579
      • Birmingham, Alabama, United States, 35233
        • Site Reference ID/Investigator# 6697
      • Huntsville, Alabama, United States, 35801
        • Site Reference ID/Investigator# 7015
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Site Reference ID/Investigator# 6728
      • Tucson, Arizona, United States, 85710
        • Site Reference ID/Investigator# 6584
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Site Reference ID/Investigator# 6696
    • California
      • Bakersfield, California, United States, 93309
        • Site Reference ID/Investigator# 6591
      • Fresno, California, United States, 93720
        • Site Reference ID/Investigator# 6710
      • Irvine, California, United States, 92697
        • Site Reference ID/Investigator# 7885
      • Los Angeles, California, United States, 90045
        • Site Reference ID/Investigator# 6872
      • Oceanside, California, United States, 92056
        • Site Reference ID/Investigator# 7669
      • San Diego, California, United States, 92103
        • Site Reference ID/Investigator# 6821
      • San Diego, California, United States, 92117
        • Site Reference ID/Investigator# 6832
      • San Diego, California, United States, 92123
        • Site Reference ID/Investigator# 7305
      • San Francisco, California, United States, 94118
        • Site Reference ID/Investigator# 7990
      • Santa Monica, California, United States, 90404
        • Site Reference ID/Investigator# 6711
      • Torrance, California, United States, 90503
        • Site Reference ID/Investigator# 8139
      • Vallejo, California, United States, 94589
        • Site Reference ID/Investigator# 7167
    • Colorado
      • Denver, Colorado, United States, 80209
        • Site Reference ID/Investigator# 7302
      • Longmont, Colorado, United States, 80501
        • Site Reference ID/Investigator# 6921
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Site Reference ID/Investigator# 6917
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Site Reference ID/Investigator# 6707
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 7301
      • Miami, Florida, United States, 33144
        • Site Reference ID/Investigator# 7012
      • Miami, Florida, United States, 33173
        • Site Reference ID/Investigator# 6831
      • South Miami, Florida, United States, 33143
        • Site Reference ID/Investigator# 7016
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 6590
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Site Reference ID/Investigator# 6582
      • Atlanta, Georgia, United States, 30327
        • Site Reference ID/Investigator# 7450
      • Newnan, Georgia, United States, 30263
        • Site Reference ID/Investigator# 6714
      • Snellville, Georgia, United States, 30078
        • Site Reference ID/Investigator# 6717
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Site Reference ID/Investigator# 7017
      • Maywood, Illinois, United States, 60153
        • Site Reference ID/Investigator# 7877
      • Skokie, Illinois, United States, 60077
        • Site Reference ID/Investigator# 6704
      • West Dundee, Illinois, United States, 60118
        • Site Reference ID/Investigator# 7292
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Site Reference ID/Investigator# 6706
      • Indianapolis, Indiana, United States, 46260
        • Site Reference ID/Investigator# 7646
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Site Reference ID/Investigator# 7014
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Site Reference ID/Investigator# 6873
      • Owensboro, Kentucky, United States, 42303
        • Site Reference ID/Investigator# 7523
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Site Reference ID/Investigator# 6597
      • Boston, Massachusetts, United States, 02111
        • Site Reference ID/Investigator# 6703
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Site Reference ID/Investigator# 7644
      • Fort Gratiot, Michigan, United States, 48059
        • Site Reference ID/Investigator# 6826
      • Grand Blanc, Michigan, United States, 48439
        • Site Reference ID/Investigator# 7989
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Site Reference ID/Investigator# 6581
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 7890
      • St. Louis, Missouri, United States, 63117
        • Site Reference ID/Investigator# 6709
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Site Reference ID/Investigator# 7451
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Site Reference ID/Investigator# 7299
      • East Windsor, New Jersey, United States, 08520
        • Site Reference ID/Investigator# 6924
      • New Brunswick, New Jersey, United States, 08903
        • Site Reference ID/Investigator# 6577
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Site Reference ID/Investigator# 7030
    • New York
      • Buffalo, New York, United States, 14221
        • Site Reference ID/Investigator# 7878
      • New York, New York, United States, 10016
        • Site Reference ID/Investigator# 7876
      • New York, New York, United States, 10025
        • Site Reference ID/Investigator# 6599
      • New York, New York, United States, 10029-6501
        • Site Reference ID/Investigator# 6895
      • New York, New York, United States, 10032
        • Site Reference ID/Investigator# 7637
      • Rochester, New York, United States, 14623
        • Site Reference ID/Investigator# 7504
      • Stoney Brook, New York, United States, 11790
        • Site Reference ID/Investigator# 7018
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Site Reference ID/Investigator# 6926
      • Wilmington, North Carolina, United States, 28401
        • Site Reference ID/Investigator# 7293
      • Winston-Salem, North Carolina, United States, 27157
        • Site Reference ID/Investigator# 8251
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 6598
      • Cleveland, Ohio, United States, 44106
        • Site Reference ID/Investigator# 8082
      • Columbus, Ohio, United States, 43212
        • Site Reference ID/Investigator# 7165
      • Dayton, Ohio, United States, 45408
        • Site Reference ID/Investigator# 7659
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Site Reference ID/Investigator# 6727
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 6894
      • Portland, Oregon, United States, 97223
        • Site Reference ID/Investigator# 6578
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 7295
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Site Reference ID/Investigator# 7879
      • Philadelphia, Pennsylvania, United States, 19103
        • Site Reference ID/Investigator# 6712
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Site Reference ID/Investigator# 6580
      • Providence, Rhode Island, United States, 02903
        • Site Reference ID/Investigator# 6576
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Site Reference ID/Investigator# 6589
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Site Reference ID/Investigator# 6586
      • Knoxville, Tennessee, United States, 37934
        • Site Reference ID/Investigator# 7668
      • Nashville, Tennessee, United States, 37215
        • Site Reference ID/Investigator# 6915
    • Texas
      • Arlington, Texas, United States, 76011
        • Site Reference ID/Investigator# 6825
      • Austin, Texas, United States, 78759
        • Site Reference ID/Investigator# 6762
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 6822
      • Dallas, Texas, United States, 75246-1613
        • Site Reference ID/Investigator# 7671
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 6705
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 6708
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7081
      • Tyler, Texas, United States, 75703
        • Site Reference ID/Investigator# 6912
      • Webster, Texas, United States, 77598
        • Site Reference ID/Investigator# 7306
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Site Reference ID/Investigator# 8101
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Site Reference ID/Investigator# 6807
    • Washington
      • Seattle, Washington, United States, 98101
        • Site Reference ID/Investigator# 6801
      • Spokane, Washington, United States, 99204
        • Site Reference ID/Investigator# 7519
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Site Reference ID/Investigator# 7080

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 is >= 18 years of age
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
  • Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

  • Subject has previous exposure to systemic 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 injectible corticosteroids
  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Arm #1 is used for entire study. At week 12, arm is rerandomized.
Drug: Placebo
Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
Active Comparator: 2
Arm #2 is used for entire study. At week 12, arm is rerandomized.
Biological: ABT-874
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
Biological: ABT-874
100mg every 12 weeks.
Active Comparator: 3
Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
Biological: ABT-874
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
Biological: ABT-874
100mg every 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PGA
Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
PASI
Time Frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12
Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12
PGA
Time Frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52
Proportion of subjects maintaining a PGA 0/1 response at Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
DLQI
Time Frame: Change from Baseline in DLQI total score vs. placebo at Week 12
Change from Baseline in DLQI total score vs. placebo at Week 12
NAPSI
Time Frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
% change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
PASI
Time Frame: Subjects who achieve PASI 90 and 100 at Week 12
Subjects who achieve PASI 90 and 100 at Week 12
Safety parameters
Time Frame: Throughout study
Throughout study

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

November 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-890

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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