Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis

• Register: EUCTR
• Last refreshed on: 30 March 2021
• Main ID: EUCTR2015-001106-33-SE
• Date of registration: 16/03/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis
• Scientific title: A randomized, double-blind, placebo-controlled multicenter study of secukinumab 150 mg in patients with active non-radiographic axial spondyloarthritis to evaluate the safety, tolerability and efficacy up to 2 years, followed by an optional phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years - PREVENT
• Date of first enrolment: 09/06/2016
• Target sample size: 555
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001106-33
• 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, Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Monaco, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Medical information
• Affiliation: Novartis Sverige AB

• Name: Medical information
• Affiliation: Novartis Sverige AB

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of axSpA according to ASAS axSpA criteria
• Objective signs of inflammation (MRI or abnormal CRP)
• Active axSpA as assessed by total BASDAI >=4 cm
• 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 been on at least 2 different NSAIDs with an inadequate response
• Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response

For the extension phase of the study:
• Patients who have completed the full study treatment period (104 weeks) in the core phase on study treatment

• 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 505
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
• Patients with radiographic evidence for sacroiliitis, grade = 2 bilaterally or grade = 3 unilaterally
• Inability or unwillingness to undergo MRI
• 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

non-radiographic axial spondyloarthritis
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis 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
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)

Main Objective: To demonstrate superiority of secukinumab 150 mg sc with loading over placebo at Week 16, based on the proportion of TNF naïve patients achieving an ASAS40 response (Assessment of SpondyloArthritis
International Society criteria).

Secondary Objective: -To demonstrate that the efficacy of secukinumab 150 mg sc:
•with or without loading, at W16 is superior to pbo based on the proportion of all patients achieving an ASAS40 response
•without loading, at W16 is superior to pbo based on the proportion of TNF naïve patients achieving an ASAS40 response.
-To demonstrate that the efficacy of secukinumab 150mg sc, with or without a loading, at W16 is superior to pbo based on:
• the proportion of patients meeting the ASAS 5/6 response criteria
• the change from baseline in total BASDAI
• the proportion of patients achieving BASDAI 50
• the change from baseline of hsCRP
• the change from baseline in total BASFI
• the change from screening in SI joint edema on MRI
• the proportion of subjects achieving an ASAS20 response
• the change from baseline in SF-36 PCS
• the change from baseline in ASQoL
• the proportion of patients achieving ASAS partial remission
-Overall safety and tolerability of secukinumab

Primary end point(s): The proportion of TNF naïve patients achieving an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria)

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

Secondary Outcome(s)

Secondary end point(s): - The proportion of all patients achieving an ASAS40 response (a)
- The proportion of TNF naïve patients achieving an ASAS40 response (a)
- The proportion of patients meeting the ASAS 5/6 response criteria (a)
- Change in BASDAI over time (a)
- The proportion of patients achieving a BASDAI 50 response (a)
- Change in hsCRP over time (a)
- Change in BASFI over time (a)
- Change in SI Joint Edema (a)
- The proportion of patients achieving an ASAS20 response (a)
- Change in SF-36 physical Component Summary over time (a)
- Change in ASQoL over time (a)
- The proportion of patients achieving an ASAS partial remission (a)
- Safety and tolerability (b)

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

Secondary ID(s)

2015-001106-33-DE

CAIN457H2315

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 09/06/2016
Contact: