16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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) 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 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