Overview

This trial is active, not recruiting.

Condition spondylitis, ankylosing
Treatments secukinumab, placebo secukinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date January 2014
End date November 2017
Trial size 226 participants
Trial identifier NCT02008916, 2013-001090-24, CAIN457F2314

Summary

The purpose of this study is to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
secukinumab AIN457
Eligible patients are randomised to each of the three treatment arms in a 1:1:1 ratio.
(Experimental)
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
secukinumab AIN457
Eligible patients are randomised to each of the three treatment arms in a 1:1:1 ratio.
(Placebo Comparator)
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients are re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
placebo secukinumab
Eligible patients are randomised to each of the three treatment arms in a 1:1:1 ratio.

Primary Outcomes

Measure
Assessment of Spondyloarthritis International Society criteria / ASAS 20 response
time frame: 16 weeks

Secondary Outcomes

Measure
ASAS 40 response
time frame: 16 weeks
Serum hsCRP
time frame: 16 weeks
ASAS 5/6 response
time frame: 16 weeks
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
time frame: 16 weeks
Pre-filled syringe usability, possible hazard and patient satisfaction assessment
time frame: Baseline to week 16
Overall safety and tolerability
time frame: 156 weeks
ASAS partial remission
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy. -- Other protocol-defined inclusion/exclusion criteria do apply.

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Novartis.