Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)

A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000046-35-GB

Enrollment

219

Registered

2012-07-20

Start date

2012-09-17

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Ankylosing spondylitis MedDRA version: 19.1 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859

Interventions

Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or non-pregnant, non-lactating female patients at least 18 years of age 2) Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) 3) Patients should have been on NSAIDs with an inadequate response 4) Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose 5) Patients who have been on an anti-TNFa agent (not more than one) must have experienced an inadequate response Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 212 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: 1) Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process 2) Patients with total ankylosis of the spine 3) Patients previously treated with any biological immunomodulating agents except for those targeting TNFa 4) Previous treatment with any cell-depleting therapies Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the efficacy of secukinumab 75mg s.c. or 150mg s.c. at Week 16 is superior to placebo in subjects with active AS based onthe proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society Criteria) response. ;Secondary Objective: 1- To demonstrate that the efficacy of at least one secukinumab regimen(75 mg or 150 mg s.c.) at Week 16 is superior to placebo based on: - the proportion of subjects achieving an ASAS 40 response - the change from baseline of hsCRP - the proportion of subjects meeting the ASAS 5/6 response criteria - the change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - the change from baseline in SF-36 PCS - the change from baseline in ASQoL - the proportion of subjects achieving an ASAS partial response 2- The overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverseevents monitoring;Primary end point(s): ASAS 20 ;Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: To demonstrate that the efficacy of secukinumab 75mg s.c. or 150mg s.c. at Week 16 is superior to placebo in subjects with active AS based onthe proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society Criteria) response. ;Secondary Objective: 1- To demonstrate that the efficacy of at least one secukinumab regimen(75 mg or 150 mg s.c.) at Week 16 is superior to placebo based on: - the proportion of subjects achieving an ASAS 40 response - the change from baseline of hsCRP - the proportion of subjects meeting the ASAS 5/6 response criteria - the change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - the change from baseline in SF-36 PCS - the change from baseline in ASQoL - the proportion of subjects achieving an ASAS partial response 2- The overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverseevents monitoring;Primary end point(s): ASAS 20 ;Timepoint(s) of evaluation of this end point: 16 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1) ASAS 40 2) Serum hsCRP 3) ASAS 5/6 response 4) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 5) Physical function component of the short-form health survey (SF-36 PCS) 6) Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) 7) ASAS partial remission 8) Overall safety and tolerability ;Timepoint(s) of evaluation of this end point: 16 weeks (1, 2, 3, 4, 5, 6, 7) 156 weeks (8)	—

Measure

Time frame

Secondary end point(s): 1) ASAS 40 2) Serum hsCRP 3) ASAS 5/6 response 4) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 5) Physical function component of the short-form health survey (SF-36 PCS) 6) Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) 7) ASAS partial remission 8) Overall safety and tolerability ;Timepoint(s) of evaluation of this end point: 16 weeks (1, 2, 3, 4, 5, 6, 7) 156 weeks (8)

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Countries

Austria, Canada, Czech Republic, Finland, Germany, Italy, Netherlands, Russian Federation, Singapore, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactMedical Information Services

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com+ 4401276698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026