NCT02826603

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,114 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Secukinumab	300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
DRUG	Ustekinumab	Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.

Timeline

• Start date: 2016-06-22
• Primary completion: 2018-07-09
• Completion: 2018-07-09
• First posted: 2016-07-11
• Last updated: 2019-07-09
• Results posted: 2019-07-09

Locations

154 sites across 11 countries: United States, Canada, Czechia, Guatemala, Hungary, Iceland, Malaysia, Poland, Slovakia, South Korea, Vietnam

Regulatory

• FDA-regulated drug study