Overview

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

Status:
Completed
Trial end date:
2018-05-16
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Antibodies, Monoclonal
Criteria
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than 3 months if therapy had to be withdrawn due to intolerance, toxicity or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