CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 675 enrolled
Drug / intervention
AIN457 150 mg +2 moredrug
Likely dose
AIN457 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/NCT01640951
NCT01640951Phase 3Completed

A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

Novartis Pharmaceuticals·interventional·Posted Jul 16, 2012·Updated May 25, 2018

In Brief

A Phase 3 clinical trial evaluating AIN457 150 mg, AIN457 300 mg, and 1 other intervention for Moderate to Severe Chronic Plaque-Type Psoriasis. Completed, enrolled 675 participants across 111 sites in 15 countries.

Detailed Summary

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Bulgaria, Canada, Czechia, France, Germany, Italy, Japan, Poland, Singapore, Slovakia, Switzerland, United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2012
Enrollment StartSep 16, 2012
Primary CompletionMay 4, 2017
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.0 years ago

Interventions

AIN457 150 mgdrug

(1 injection per dose) and placebo to Secukinumab 150 mg

AIN457 300 mgdrug

Secukinumab 150 mg (2 injections per dose)

Placebodrug