Phase 3 N=555 Randomized Quadruple-blind Treatment

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

Non-radiographic Spondyloarthritis

Bottom Line

View on ClinicalTrials.gov: NCT02696031 ↗

Enrolled (actual)

555

Serious AEs

8.2%

Results posted

Aug 2020

Primary outcome: Primary: The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16 — 68; 70; 50 Participants — p=0.0197

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Secukinumab (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16	68; 70; 50	0.0197 sig
PRIMARY The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52	58; 66; 34	0.0017 sig
SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response	74; 75; 52; 62; 70; 36	0.0108 sig
SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response	105; 107; 85	0.0260 sig
SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response	74; 66; 44	0.0005 sig
SECONDARY The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)	40; 39; 13	<.0001 sig
SECONDARY Change in Bath Ankylosing Spondylitis Functional Index (BASFI)	-1.75; -1.64; -1.01	0.0041 sig
SECONDARY The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response	69; 69; 39; 57; 65; 37	0.0001 sig
SECONDARY Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-2.35; -2.43; -1.46	0.0006 sig
SECONDARY Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16	-3.45; -3.62; -1.84	0.0008 sig
SECONDARY Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52	-7.1; -7.6; -6.4	0.0012 sig
SECONDARY The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease	29; 44; 19	0.0577
SECONDARY Change in High Sensitivity C-reactive Protein	0.64; 0.64; 0.91	0.0002 sig
SECONDARY Change in Short Form-36 Physical Component Summary (SF-36 PCS)	5.71; 5.57; 2.93	0.0006 sig
SECONDARY Change in Sacroiliac Joint Edema - Week 16	-1.68; -1.03; -0.39	<0.0001 sig
SECONDARY Change in Sacroiliac Joint Edema - Week 52	-2.9; -1.9; -0.1	<.0001 sig

Summary

The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Eligibility Criteria

Inclusion Criteria

Male or non-pregnant, non-nursing female patients at least 18 years of age
Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response

Exclusion Criteria

Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
Inability or unwillingness to undergo MRI
Chest X-ray or MRI with evidence of ongoing infectious or malignant process
Patients taking high potency opioid analgesics
Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
Pregnant or nursing (lactating) women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02696031). 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.