NCT02409667

Plaque Psoriasis Efficacy and Safety With Secukinumab

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16,487 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab	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.

Timeline

• Start date: 2015-05-07
• Primary completion: 2017-03-14
• Completion: 2017-05-08
• First posted: 2015-04-07
• Last updated: 2019-05-13
• Results posted: 2019-05-13

Locations

200 sites across 24 countries: Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, United Kingdom