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)

• Register: EUCTR
• Last refreshed on: 6 November 2018
• Main ID: EUCTR2012-000046-35-DE
• Date of registration: 19/09/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: 20/12/2012
• Target sample size: 219
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000046-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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 Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

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 Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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 on the 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 adverse
events monitoring

Timepoint(s) of evaluation of this end point: 16 weeks

Primary end point(s): ASAS 20

Secondary Outcome(s)

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)

Secondary ID(s)

2012-000046-35-GB

CAIN457F2310

Source(s) of Monetary Support

Novartis Pharma Services AG