At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,346 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Ixekizumab 80 mg SC; Etanercept 50 mg SCAI-extracted
Key inclusion· 4
- ✓Chronic plaque psoriasis confirmed for ≥6 months before randomization
- ✓At least 10% Body Surface Area (BSA) affected at screening and randomization
- ✓sPGA score ≥3 and PASI score ≥12 at screening and randomization
- ✓Candidate for phototherapy and/or systemic therapy
Key exclusion· 8
- ✕Pustular, erythrodermic, or guttate forms of psoriasis
- ✕History of drug-induced psoriasis
- ✕Prior use of etanercept
- ✕Clinically significant psoriasis flare within 12 weeks before randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
In Brief
A Phase 3 clinical trial evaluating Placebo, 50 mg etanercept, and 1 other intervention for Psoriasis. Completed, enrolled 1,346 participants across 101 sites in 10 countries.
Detailed Summary
This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesArgentina, Bulgaria, Canada, Chile, Germany, Hungary, Mexico, Poland, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartJul 2012
Primary CompletionMay 2014
Study CompletionJul 2019
TodayJul 2026
First PostedJul 20, 2012
Enrollment StartJul 28, 2012
Primary CompletionMay 22, 2014
Study CompletionJul 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.0 years ago
Interventions
Placebodrug
Administered SC
50 mg etanerceptdrug
Administered SC
80 mg ixekizumabdrug
Administered SC