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ASLeap


Title  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)   
Therapeutic Area Ankylosing Spondylitis
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 18 Years
Gender Any
Contact Vivian Deng
617-636-5727
More Information https://www.clinicaltrials.gov/ct2/show/NCT03350815

Overview

The purpose of this study is to estimate the difference in clinical response between 300 mg and 150 mg of secukinumab at Week 52 in patients with Ankylosing Spondylitis (AS). Patients will be on an open-label secukinumab 150 mg until Week 16, followed by a randomization phase to receive either secukinumab 150 mg or secukinumab 300 mg. This study will also investigate the link between secukinumab and sleep disturbances, and daytime activity patterns.

Study Details

Inclusion Criteria

  • Patients with active Ankylosing Spondylitis
  • Patients who are currently on stable treatment for ankylosing spondylitis
  • Patients who are not pregnant

Exclusion Criteria

  • Patients who have total ankylosis of the spine
  • Patients with previous exposure to secukinumab or any other biologic drug directly targeting IL-17, IL12/23, or the IL-17 receptor, or any other biologic immunomodulating agent
  • Patients with active ongoing inflammatory diseases other than AS.

Study Requirements

The study includes a total of 19 visits to Tufts Medical Center over a period of approximately one year. Each visit will require blood and urine collection and the first visit will require a chest X-ray. Patients will wear an actigraphy device and answer questionnaires about sleep every day until Week 16. Secukinumab will be self-administered subcutaneously weekly for the first four weeks, and every four weeks thereafter.