Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02896127
• Date of registration: 04/05/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• 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
• Date of first enrolment: October 18, 2016
• Target sample size: 458
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02896127
• 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

China, Czech Republic, Czechia, Korea, Republic of, United Kingdom

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

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randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance,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

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



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

Health Condition(s) or Problem(s) studied

Ankylosing Spondyloarthritis

Intervention(s)

Drug: Placebo

Drug: Secukinumab

Primary Outcome(s)

The proportion of participants who achieve an ASAS 20 response (Assessment of SpondyloArthritis International Society criteria) [Time Frame: Week 16]

Secondary Outcome(s)

The proportion of participants who achieve an ASAS 40 reponse [Time Frame: Week 16]

Change in BASDAI over time [Time Frame: Week 16]

The proportion of patients who achieve an ASAS partial remission [Time Frame: Week 16]

Change in SF-36 PCS over time [Time Frame: Week 16]

The proportion of participants who achieve an ASAS 5/6 [Time Frame: Week 16]

Change in hsCRP over time [Time Frame: Week 16]

Change in ASQoL score over time [Time Frame: Week 16]

Secondary ID(s)

2015-005021-39

CAIN457F2308

Source(s) of Monetary Support

Please refer to primary and secondary sponsors