An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis

Phase 3

• Conditions: Ankylosing Spondylitis

• Registration Number: JPRN-jRCT2080223186
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 30

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months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications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 TNFalpha 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-TNFalpha agent

Exclusion Criteria

-Patients with total ankylosis of the spine
-Patients previously treated with any biological immunomodulating agents except for those targeting TNFalpha
-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified