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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00570986
First received: December 7, 2007
Last updated: February 6, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: Placebo
Biological: ABT-874
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 ] [ Designated as safety issue: No ]
  • PASI [ Time Frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 ] [ Designated as safety issue: No ]
  • PGA [ Time Frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DLQI [ Time Frame: Change from Baseline in DLQI total score vs. placebo at Week 12 ] [ Designated as safety issue: No ]
  • NAPSI [ Time Frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis ] [ Designated as safety issue: No ]
  • PASI [ Time Frame: Subjects who achieve PASI 90 and 100 at Week 12 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 1465
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: 3
Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
Biological: ABT-874
100mg every 12 weeks.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570986

  Show 116 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Martin Kaul, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00570986     History of Changes
Other Study ID Numbers: M06-890
Study First Received: December 7, 2007
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014