16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2013-001090-24-BE
• Date of registration: 14/01/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients
• Scientific title: A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis
• Date of first enrolment: 13/02/2014
• Target sample size: 222
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001090-24
• 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

Belgium, Czech Republic, Germany, Greece, Mexico, Norway, Portugal, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Trial Infromation Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Infromation Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
- Moderate to severe AS
- Prior radiographic evidence according to the Modified NY Criteria (1984)
- Inadequate response to NSDAIDs
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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
- Pregnancy or lactation
- Ongoing 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-defined exclusion critera may apply


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

Health Condition(s) or Problem(s) studied

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

Ankylosing spondylitis
MedDRA version: 16.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF alpha therapy.

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

Secondary Objective: -To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on:
1- the proportion of subjects achieving an ASAS 40 response
2- the change from baseline of hsCRP
3- the proportion of patients meeting the ASAS 5/6 response criteria
4- the change from baseline in total BASDAI
5- the change from baseline in the proportion of patients achieving ASAS partial remission
-To assess PFS usability utilizing the Self-Injection assessment checklist and Possible Hazard assessment checklist and to assess subject satisfaction with PFS utilizing the SIAQ
-Overall safety and tolerability of secukinumab LiV and PFS formulations 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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 to 4: 16 weeks
5: Baseline to Week 16
6: 156 weeks

Secondary end point(s): 1- ASAS 40 response
2- Serum hsCRP
3- ASAS 5/6 response
4- Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
5- Pre-filled syringe usability, possible hazard and patient satisfaction assessment
6- Overall safety and tolerability

Secondary ID(s)

CAIN457F2314

2013-001090-24-DE

Source(s) of Monetary Support

Novartis Pharma Services AG