TROPOS: designing a clinical trial to evaluate the oral corticosteroid-sparing effect of a biologic in severe asthma

Abstract

In a Phase IIb study, administration of tralokinumab, an anti-IL-13, fully human monoclonal antibody, to patients with severe uncontrolled asthma treated with high-dose inhaled corticosteroid (ICS) and long-acting β2-agonists (LABA) significantly improved lung function. Since many patients with severe asthma using ICS-LABA only achieve symptom control with add-on oral corticosteroids (OCS), an unmet need for OCS-sparing treatment strategies exists. This Phase III, randomized, double-blind, parallel-group, placebo-controlled TROPOS (NCT02281357) study will evaluate the OCS-sparing potential of tralokinumab in patients with severe asthma requiring continuous ICS-LABA and chronic maintenance OCS. After an initial screening/assessment period, patients will be randomized to tralokinumab or placebo for 40 weeks (12-week induction, 20-week OCS reduction and 8-week maintenance phases); patients will be followed-up for 14 weeks.