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

• Status: Completed
• Trial end date: 2019-03-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of secukinumab compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 52.

• 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 or radiologist's report) fulfilling the Modified New York criteria for AS:

• Active AS assessed by BASDAI ≥4 (0-10) at Baseline

• Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at Baseline

• Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline Patients should have had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation 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 randomization or have been intolerant to at least one administration of an anti-TNFα agent

Exclusion Criteria:

• Chest X-ray or MRI with evidence of ongoing infectious or malignant process

• Patients taking high potency opioid analgesics

• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor

• Pregnant or nursing (lactating) women