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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00292396
First received: February 14, 2006
Last updated: January 10, 2013
Last verified: January 2013

February 14, 2006
January 10, 2013
November 2005
April 2008   (final data collection date for primary outcome measure)
Proportion of subjects with clinical response relative to Baseline PASI score [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ]
Proportion of subjects with clinical response relative to Baseline PASI score
Complete list of historical versions of study NCT00292396 on ClinicalTrials.gov Archive Site
  • Quality of Life Surveys [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: Yes ]
  • Clinical response indicators [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Monthly through duration of study ] [ Designated as safety issue: Yes ]
  • PGA Assessment [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ]
QOLs, clinical response indicators, safety parameters
Not Provided
Not Provided
 
Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: Anti IL-12 monoclonal antibody/ABT-874
    Please see Arm Description for intervention description and details.
  • Drug: placebo
    12 doses
  • Active Comparator: 1
    Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
    Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
  • Active Comparator: 2
    Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
    Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
  • Active Comparator: 3
    Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
    Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
  • Active Comparator: 4
    Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
    Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
  • Active Comparator: 5
    Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
    Intervention: Drug: Anti IL-12 monoclonal antibody/ABT-874
  • Placebo Comparator: 6
    placebo, 12 doses
    Intervention: Drug: placebo
Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00292396
M05-736
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Chair: Martin Kaul, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP