This trial is active, not recruiting.

Condition anklyosing spondylitis
Treatments secukinumab (75 mg), placebo, secukinumab (150 mg)
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date October 2012
End date October 2018
Trial size 220 participants
Trial identifier NCT01649375, 2012-000046-35, CAIN457F2310


This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are tolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Secukinumab 75 mg once weekly at BSL, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks. Patients may be escalated to 150 mg as judged appropriate by investigator.
secukinumab (75 mg)
Secukinumab 75 mg s.c.
Secukinumab 150 mg once weekly at BSL, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
secukinumab (150 mg) Secukinumab 150 mg
Secukinumab 150 mg s.c.
(Placebo Comparator)
Placebo once weekly at BSL, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks

Primary Outcomes

Assessment of SpondyloArthritis International Society / ASAS 20 response
time frame: 16 weeks

Secondary Outcomes

ASAS 40 response
time frame: 16 weeks
Serum hsCRP
time frame: 16 weeks
ASAS 5/6 response
time frame: 16 weeks
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
time frame: 16 weeks
Physical function component of the short-form health survey / SF-36 PCS
time frame: 16 weeks
Ankylosing Spondylitis Quality of Life questionnaire / ASQoL
time frame: 16 weeks
ASAS partial remission
time frame: 16 weeks
Overall safety and tolerability
time frame: 156 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or non-pregnant, non-lactating female patients - Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) - Patients should have been on NSAIDs with an inadequate response - Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose - Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response Exclusion Criteria: - Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process - Patients with total ankylosis of the spine - Patients previously treated with any biological immunomodulating agents except for those targeting TNFα - Previous treatment with any cell-depleting therapies - Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.