CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 177 enrolled
Drug / intervention
secukinumab 150 mg +2 moredrug
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.

Search/NCT01555125
NCT01555125Phase 3Completed

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

Novartis Pharmaceuticals·interventional·Posted Mar 15, 2012·Updated Aug 8, 2018

In Brief

A Phase 3 clinical trial evaluating secukinumab 150 mg, secukinumab 300 mg, and 1 other intervention for Moderate to Severe Plaque-type Psoriasis. Completed, enrolled 177 participants across 33 sites in 5 countries.

Detailed Summary

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Estonia, France, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2012
Enrollment StartMay 8, 2012
Primary CompletionOct 24, 2016
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.3 years ago

Interventions

secukinumab 150 mgdrug

After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period

secukinumab 300 mgdrug

After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period

placebodrug

Subjects who were on placebo at Week 52 cannot continue in the extension treatment period