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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014