Phase 3 N=371 Randomized Quadruple-blind Treatment

16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT01358175 ↗

Enrolled (actual)

371

Serious AEs

10.6%

Results posted

Jan 2017

Primary outcome: Primary: Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response — 59.7; 60.8; 28.7 % responders — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Secukinumab (75 mg) (Drug); Secukinumab (150 mg) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response	59.7; 60.8; 28.7	<0.0001 sig
SECONDARY Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response	33.1; 41.6; 13.1	—
SECONDARY Change From Baseline in Serum hsCRP	0.45; 0.4; 0.97	—
SECONDARY Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response	45.2; 48.8; 13.1	—
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI	-2.34; -2.32; -0.59	—
SECONDARY Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS	5.64; 5.57; 0.96	—
SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL	-3.61; -3.58; -1.04	—
SECONDARY Assessment of Responders for ASAS Partial Remission	16.1; 15.2; 3.3	—

Summary

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Eligibility Criteria

Inclusion criteria

Male or non-pregnant, non-lactating female patients at least 18 years of age
Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
Patients should have been on NSAIDs with an inadequate response
Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion criteria

Chest X-ray with evidence of ongoing infectious or malignant process
Patients with total ankylosis of the spine
Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
Previous treatment with any cell-depleting therapies
Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01358175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.