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
  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:


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
Interleukin-12
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 23, 2014