NCT00710580CompletedPhase 3
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
AbbVie (prior sponsor, Abbott)42 sites in 1 country350 target enrollmentStarted: July 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 350
- Locations
- 42
- Primary Endpoint
- Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Study Overview
Brief Summary
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Psoriasis for 6 MO
- •PASI 12 or above
- •PGA 3 or above
Exclusion Criteria
- •Previous exposure to either etanercept or ABT-874
Arms & Interventions
A
Experimental
Intervention: ABT-874 (Biological)
B
Active Comparator
Intervention: etanercept (Biological)
C
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Time Frame: 12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
Time Frame: 12 Weeks
Secondary Outcomes
- Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12(12 Weeks)
Investigators
Study Sites (42)
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