Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2021
• Main ID: NCT02696031
• Date of registration: 13/10/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis PREVENT
• Scientific title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs
• Date of first enrolment: April 29, 2016
• Target sample size: 555
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02696031
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or non-pregnant, non-nursing female patients at least 18 years of age

- Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis
International Society (ASAS) axial spondyloarthritis criteria

- objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal
C-reactive protein)

- active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis
Disease Activity Index >=4 cm

- Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question
#2 = 4 cm (0-10 cm) at baseline

- Total back pain as measured by Visual Analogue scale = 40 mm (0-100 mm) at baseline

- Patients should have been on at least 2 different non-steroidal anti-inflammatory
drugs with an inadequate response

- Patients who have been on a TNFa inhibitor (not more than one) must have experienced
an inadequate response

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
interleukin-17 (IL-17) or IL-17 receptor

- Pregnant or nursing (lactating) women



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-radiographic Spondyloarthritis

Intervention(s)

Drug: Placebo

Drug: Secukinumab

Primary Outcome(s)

The Proportion of TNF Naive Participants Who Achieved an ASAS 40 Response (Assessment of SpondyloArthritis International Society Criteria) [Time Frame: Week 16]

The Proportion of TNF Naive Participants Who Achieved an ASAS 40 Response (Assessment of SpondyloArthritis International Society Criteria) [Time Frame: Week 52]

Secondary Outcome(s)

Change in BASFI (Bath Ankylosing Spondylitis Functional Index) Over Time [Time Frame: Week 16]

The Proportion of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease [Time Frame: Week 52]

Change in SF-36 (Short Form-36 Physical Component Summary) Physical Component Summary Over Time [Time Frame: Week 16]

Change in ASQoL (Ankylosing Spondylitis Quality of Life Scores) Over Time - Week 52 [Time Frame: Week 52]

The Proportion of Participants Who Achieved an ASAS 5/6 [Time Frame: Week 16]

Change in ASQoL (Ankylosing Spondylitis Quality of Life Scores) Over Time - Week 16 [Time Frame: Week 16]

Change in Sacroiliac Joint Edema [Time Frame: Week 16 and 52]

Change in Sacroiliac Joint Edema - Week 52 [Time Frame: Week 52]

The Proportion of Patients to Achieve a BASDAI 50 Response [Time Frame: Week 16 and 52]

Change in High Sensitivity C-reactive Protein Over Time [Time Frame: Week 16]

The Proportion of Participants Who Achieved an ASAS 20 Response [Time Frame: Week 16]

Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) Over Time [Time Frame: Week 16]

Secondary ID(s)

CAIN457H2315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02696031