A randomized double-blind parallel-group multicenter study of secukinumab to compare 300 mg and 150 mg at Week 52 in patients with Ankylosing Spondylitis who are randomized to dose escalation after not achieving inactive disease during an initial 16 weeks of open-label treatment with secukinumab 150 mg (ASLeap)

Brief description of study

The purpose of the study is to determine the safety and benefit of taking secukinumab 300mg, compared to 150mg, in patients with active ankylosing spondylitis. This study will also look to see if treatment with secukinumab has an impact on daily activity and quality of sleep. Secukinumab is a prescription medicine that has been approved by the FDA for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and active ankylosing spondylitis in adults. The use of the 300mg dose for ankylosing spondylitis has not been approved by the FDA, however, and is therefore considered investigational. Secukinumab is known as a biologic, and works by blocking the activity of a specific protein in the immune system, interlukin-17A, which is believed to be involved in psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Clinical Study Identifier: s18-00298
ClinicalTrials.gov Identifier: NCT03350815
Principal Investigator: David H. Goddard.

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