NCT03066609

Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 543 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Secukinumab 150 mg s.c.	150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
DRUG	Secukinumab 300 mg s.c.	300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
DRUG	Placebo	Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-12-21
• Completion: 2018-11-20
• First posted: 2017-02-28
• Last updated: 2019-12-30
• Results posted: 2019-12-30

Locations

32 sites across 6 countries: China, Hungary, Malaysia, Philippines, Thailand, Turkey (Türkiye)