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

Novartis

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02750592

CAIN457H1301

Details and patient eligibility

About

The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline
• Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
• Patients who have been on a TNFα 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 baseline or have been intolerant to at least one administration of an anti-TNFα agent

Exclusion criteria

• Patients with total ankylosis of the spine
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
• Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
• Known infection with HIV, hepatitis B or hepatitis C at screening or baseline

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

secukinumab 150mg

Experimental group

Description:

A screening (SCR) epoch running 4-10 weeks before baseline (BSL) was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consist of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 follows a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinue prematurely.

Treatment:

Drug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.