Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2015-005021-39-GB
• Date of registration: 12/07/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.
• Scientific title: A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5
• Date of first enrolment: 04/08/2016
• Target sample size: 454
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005021-39
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

China, Czech Republic, Korea, Democratic People's Republic of, United Kingdom

Contacts

• Name: Medica Information Services
• Affiliation: Novartis Pharmaceuticals UK Limited

• Name: Medica Information Services
• Affiliation: Novartis Pharmaceuticals UK Limited

Key inclusion & exclusion criteria

Inclusion criteria:
Male or non-pregnant, non-lactating female patients at least 18 years of age
Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist’s report) fulfilling the Modified New York criteria for AS:
- Active AS assessed by BASDAI =4 (0-10) at Baseline
- Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at Baseline
- Total back pain as measured by VAS = 40 mm (0-100 mm) at Baseline
Patients should have had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications
Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation
Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFa agent

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 441
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion criteria:
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 IL-17 or IL-17 receptor
Pregnant or nursing (lactating) women

Other protocol-defined exclusion criteria 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 Spondyloarthritis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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
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)

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

Primary end point(s): The proportion of participants who achieve an ASAS 20 response
(Assessment of SpondyloArthritis International Society criteria)

Main Objective: To demonstrate that the efficacy of secukinumab 150 mg s.c. at Week 16 is superior to placebo in subjects with active AS based on the proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response.

Secondary Objective: To demonstrate that the efficacy of secukinumab 150 mg s.c. 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 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 Short Form 36 physical component score (SF-36 PCS)
- the change from baseline in Ankylosing Spondylitis Quality of Life score (ASQoL)
- the proportion of subjects achieving an ASAS partial remission

Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse event monitoring

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: a)Week 16
b)Week 60

Secondary end point(s): The proportion of participants who achieve an ASAS 40 reponse (a)
Change in hsCRP over time (a)
The proportion of participants who achieve an ASAS 5/6 (a)
Change in BASDAI over time (a)
Change in SF-36 PCS over time (a)
Change in ASQoL score over time (a)
The proportion of patients who achieve an ASAS partial remission (a)
Safety and Tolerability (b)

Secondary ID(s)

CAIN457F2308

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact: