At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 16,487 enrolled
Drug / intervention
Secukinumabbiological
Likely dose
Secukinumab 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.
In Brief
A Phase 3 clinical trial evaluating Secukinumab for Plaque Psoriasis. Completed, enrolled 16,487 participants across 200 sites in 24 countries.
Detailed Summary
To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
CountriesAustria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartMay 2015
Primary CompletionMar 2017
Study CompletionMay 2017
TodayJul 2026
First PostedApr 7, 2015
Enrollment StartMay 7, 2015
Primary CompletionMar 14, 2017
Study CompletionMay 8, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.2 years ago
Interventions
Secukinumabbiological
Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.