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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Psoriasis
 Drug: Anti IL-12 monoclonal antibody/ABT-874
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: November 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
 Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
Active Comparator: 2
Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
 Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
Active Comparator: 3
Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
 Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
Active Comparator: 4
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
 Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
Active Comparator: 5
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
 Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
Placebo Comparator: 6
placebo, 12 doses
 Drug: placebo
12 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292396

  Show 24 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Martin Kaul, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00292396     History of Changes
Other Study ID Numbers: M05-736
Study First Received: February 14, 2006
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013