Overview

This trial is active, not recruiting.

Condition spondylitis, ankylosing
Treatments secukinumab, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date May 2015
End date January 2018
Trial size 350 participants
Trial identifier NCT02159053, 2013-005575-41, CAIN457F2320

Summary

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα 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)
Secukinumab 150 mg at Baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
secukinumab Secukinumab (AIN457) 150 mg s.c.
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
(Experimental)
Secukinumab 150 mg at Baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2, and 3.
secukinumab Secukinumab (AIN457) 150 mg s.c.
Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
(Placebo Comparator)
Placebo at Baseline, Weeks 1, 2, 3, 4, 8, and 12, followed by dosing with Secukinumab 150 mg every four weeks starting at Week 16.
placebo
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Primary Outcomes

Measure
Assessment of Spondyloarthritis International Society criteria / ASAS 20
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
Short Form-36 Physical Component Summary (SF-36 PCS) health survey
time frame: 16 weeks
Ankylosing Spondylitis Quality of Life (ASQoL)
time frame: 16 weeks
Overall safety and tolerability
time frame: 112 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 Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.