SUNRISE – A randomised, double-blind, parallel-group, placebo-controlled 28-week phase 3 efficacy & safety study of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma

Purpose of trial

The purpose of this global study is to demonstrate the ability of tezepelumab, compared with placebo, to reduce oral corticosteroid (OCS) use in adults with severe asthma who are being treated with maintenance OCS in combination with high dose inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA), with or without other asthma controller therapies, while maintaining asthma control. Oral corticosteroids are effective agents for controlling airway inflammation in asthma. However, when given for extended periods of time, OCS are associated with multiple and potentially debilitating side effects. In previous OCS-sparing studies using tezepelumab there has been a reduction in OCS use in participants with OCS-dependent asthma. SUNRISE has been designed to incorporate learnings from the previous studies.

Eligibility

• Participants must be 19 - 80 years old at the time of signing the informed consent
• They must have asthma diagnosed by a doctor for ≥12 months
• Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of ≥ 7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least one month prior to Visit 1
• Participants must have received medium- or high-dose ICS for at least 12 months prior to Visit 1
• They must have received LABA and high dose ICS for at least 3 months prior to Visit 1.
• Additional asthma controller medications are allowed according to standard practice of care. The use of these medications must be documented for at least 3 months prior to Visit 1.
• Other criteria will be discussed

Resources

National Library of Medicine trial link