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

A randomized, double-blind, placebo-controlled multicenter study of secukinumab 150 mg in patients with active non-radiographic axial spondyloarthritis to evaluate the safety, tolerability and efficacy up to 2 years, followed by an optional phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223230

Enrollment

Registered

2016-06-06

Start date

2016-04-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-radiographic Spondyloarthritis

Interventions

investigational material(s) Generic name etc : Secukinumab INN of investigational material : Cosentyx Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion 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 TNFalfa inhibitor (not more than one) must have experienced an inadequate response

Exclusion criteria

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 Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy The proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 16, 52 ] ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of >=40% and >=2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain	—

Measure

Time frame

efficacy The proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 16, 52 ] ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of >=40% and >=2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain

—

Secondary

Measure	Time frame
efficacy The proportion of participants who achieved an ASAS 5/6 [ Time Frame: Week 16 ] The ASAS 5/6 improvement criteria is an improvement of >=20% in at least five of all six domains efficacy Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time [ Time Frame: Week 16 ] The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS safety Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time [ Time Frame: Week 16 and 52 ] The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions	—

Measure

Time frame

efficacy The proportion of participants who achieved an ASAS 5/6 [ Time Frame: Week 16 ] The ASAS 5/6 improvement criteria is an improvement of >=20% in at least five of all six domains efficacy Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time [ Time Frame: Week 16 ] The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS safety Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time [ Time Frame: Week 16 and 52 ] The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions

—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026