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

• Register: EUCTR
• Last refreshed on: 23 October 2023
• Main ID: EUCTR2015-001106-33-ES
• Date of registration: 18/02/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica S.A.
• 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 to evaluate the safety, tolerability and efficacy up to 2 years in patients with active non-radiographic axial spondyloarthritis
• Date of first enrolment: 04/05/2016
• 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, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Departamento Médico
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico
• Affiliation: Novartis Farmacéutica, S.A.

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 n.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 TNF alpha inhibitor (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 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: 18.1 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/ml milligram(s)/millilitre
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): The proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria)

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

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 patients meeting the ASAS 5/6 response criteria
- the change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- the proportion of patients achieving BASDAI 50
- the change from baseline of high sensitivity C-Reactive Protein (hsCRP)
- the change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS)
- the proportion of subjects achieving an ASAS20 response
- the change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI)
- the change from screening in SI joint edema on MRI
- the proportion of patients achieving ASAS partial remission
- Overall safety and tolerability of secukinumab

Main Objective: To demonstrate superiority of secukinumab 150 mg s.c., with or without loading, over placebo at Week 16, based on the proportion of patients achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria).

Secondary Outcome(s)

Secondary end point(s): - The proportion of participants who achieved an ASAS 5/6 (a)
- Change in BASDAI over time (a)
- The proportion of patients to achieve a BASDAI 50 response (a)
- Change in hsCRP over time (a)
- Change in SF-36 physical Component Summary over time (a)
- The proportion of participants who achieved an ASAS 20 response (a)
- Change in BASFI over time (a)
- Change in SI Joint Edema (a)
- The proportion of patients who achieved 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: 26/04/2016
Contact:

Results

• Results available: Yes
• Date Posted: 13/12/2021
• Date Completed: 11/03/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-001106-33/results