16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis

• Register: EUCTR
• Last refreshed on: 12 March 2018
• Main ID: EUCTR2013-005575-41-DK
• Date of registration: 25/02/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis
• Scientific title: A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4
• Date of first enrolment: 13/04/2015
• Target sample size: 324
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005575-41
• 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

Australia, Austria, Bulgaria, Canada, Czech Republic, Denmark, Finland, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Russian Federation, Slovakia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Medicinsk information
• Affiliation: Novartis Healthcare A/S

• Name: Medicinsk information
• Affiliation: Novartis Healthcare A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- Moderate to severe AS
- Prior radiographic evidence according to the Modified NY Criteria (1984)
- Inadequate response to NSAIDs
Other protocol-definied 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 304
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
- Pregnancy or lactation
- On-going infectious or malignant process on a chest X-ray or MRI
- Previous exposure to IL-17 or IL-17R targeting therapies
- Previous exposure to any biological immunomodulating agent excluding TNF antagonists
- Previous cell depleting therapy
Other protocol-definied exclusion criteria may apply.


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

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

Intervention(s)

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
Other descriptive name: SECUKINUMAB
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

Primary Outcome(s)

Primary end point(s): Assessment of Spondyloarthritis International Society criteria, ASAS 20

Secondary Objective: -To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at Week 16 is superior to placebo based on
•the proportion of subjects achieving an ASAS40 response
•the change from baseline of high sensitivity C-Reactive Protein (hsCRP)
•the proportion of patients meeting the ASAS 5/6 response criteria
•the change from baseline in total Bath Ankylosing Spondylitis Disease Activity (BASDAI)
•the change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
•the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)
-To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at
Week 4 is superior to placebo based on:
•the proportion of subjects achieving an ASAS20 response
•the proportion of subjects achieving an ASAS40 response
- Overall safety and tolerability of secukinumab

Main Objective: To demonstrate that the efficacy of secukinumab 150 mg at Week 16 with or without a loading regimen is superior to placebo based on the proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response.

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

Secondary Outcome(s)

Secondary end point(s): - ASAS 40 response (a)
- Serum hsCRP (a)
- ASAS 5/6 response (a)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (a)
- Short Form-36 Physical Compenent Summary (SF-36 PCS) health survey (a)
- Ankylosing Spondylitis Quality of Life (ASQoL) (a)
- Overall safety and tolerability (b)

Timepoint(s) of evaluation of this end point: (a) 16 weeks
(b) 112 weeks

Secondary ID(s)

2013-005575-41-CZ

CAIN457F2320

Source(s) of Monetary Support

Novartis Pharma Services AG