Novartis has announced the initiation of the ASLeap trial in patients with ankylosing spondylitis (AS), evaluating the effect of changing to a higher dose (300 mg) of Cosentyx (secukinumab) in patients who do not achieve symptom remission after treatment with Cosentyx 150 mg for 16 weeks. The primary endpoint of ASLeap is to determine the difference between Cosentyx 300 mg and Cosentyx 150 mg at Week 52 based on the proportion of subjects achieving inactive disease status based on the Ankylosing Spondylitis Disease Activity Score (ASDAS).
"An important goal of ankylosing spondylitis treatment is to provide as much symptom relief as possible for patients living with this debilitating disease," said Marcia Kayath, Head US Clinical Development and Medical Affairs, Novartis Pharmaceuticals Corporation. "While Cosentyx 150 mg has shown clinically significant results in treating a majority of patients with AS, we want to investigate whether some patients may benefit from a higher dose. We hope that the results of the ASLeap study will help provide physicians with important information about how best to manage these patients."
An exploratory analysis will also assess sleep disturbance and daytime activity in patients with AS, as measured by the use of a wearable motion biosensor, an Actiwatch device, which is a medical device resembling a wristwatch used to collect detailed information on sleep and physical activity. Patients with AS report chronic and extensive sleep disturbance due to pain and stiffness during the night. In AS patients, poor quality sleep is strongly correlated with increased pain, fatigue, lower quality of life, higher depressed mood, higher disease activity and reduced physical function.
The study is expected to begin enrollment in January 2018 and aims to enroll approximately 270 patients at 70 centers in the United States.
The ASLeap study design includes an initial 16 week open-label period (Treatment Period 1), followed by a randomized, double-blind, parallel-group period (Treatment Period 2). During the initial 16 weeks of the trial, all patients will receive open-label 150 mg Cosentyx. At Week 16, based on whether patients have met the definition of ASDAS inactive disease, patients will be placed into one of the following three groups for the remaining 36 weeks of the trial: Responders, patients who achieve ASDAS inactive disease (total score <1.3) at both Week 12 and Week 16, will enter Treatment Period 2 and continue receiving blinded Cosentyx 150 mg through Week 48. Inadequate Responders, patients who are not in inactive disease status, defined as an ASDAS total score of =1.3, at both Week 12 and Week 16, will enter Treatment Period 2 and be randomized (1:1, double-blinded) to Cosentyx 300 mg or Cosentyx 150 mg through Week 48. Non-responders, patients who exhibit no change or an increase (worsening) from baseline in total ASDAS score at either Week 12 or Week 16, will complete the study at Week 16.
The study population will consist of male and female patients, =18 years of age with a clinical diagnosis of moderate to severe AS fulfilling the Modified New York criteria for AS despite previous or current NSAIDs/non-biologic DMARDs and/or anti-TNFa therapy. Patients must have active AS, as measured by the following: total BASDAI =4 on a scale of 0-10 at baseline, spinal pain as measured by BASDAI question #2 =4 on a scale of 0-10 at baseline, and total back pain as measured by visual analog scale (VAS) =40mm (0-100 mm) at baseline.