CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 543 enrolled
Drug / intervention
Secukinumab 150 mg s.c. +2 moredrug
Likely dose
Secukinumab 150 mg s.c.from 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.

Search/NCT03066609
NCT03066609Phase 3Completed

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

Novartis Pharmaceuticals·interventional·Posted Feb 28, 2017·Updated Dec 30, 2019

In Brief

A Phase 3 clinical trial evaluating Secukinumab 150 mg s.c., Secukinumab 300 mg s.c., and 1 other intervention for Plaque Psoriasis. Completed, enrolled 543 participants across 32 sites in 6 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Hungary, Malaysia, Philippines, Thailand, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 28, 2017
Enrollment StartFeb 28, 2017
Primary CompletionDec 21, 2017
Study CompletionNov 20, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.3 years ago

Interventions

Secukinumab 150 mg s.c.drug

150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Secukinumab 300 mg s.c.drug

300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Placebodrug

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