Patients and caregivers’ core aspirations to maximize the attractiveness of ASPIRE - a phase 2b trial to investigate the disease modifying potential of buloxibutid in IPF

The unmet medical need in idiopathic pulmonary fibrosis (IPF) remains monumental with multiple trials failing to show stabilization and improvement. Additionally, many clinical trials fail to recruit enough participants or suffer high dropout rates, increasing the hurdles for developing new and effective therapies. To increase the probability of success of ASPIRE, a 52-week, phase 2b trial of buloxibutid (C21), an oral angiotensin II type 2 (AT2) receptor agonist with disease modifying potential, Vicore established an advisory panel with six IPF patients and two caregivers from the United States and United Kingdom. Semi-structured panel discussions and individual interviews captured feedback on previous clinical trial experiences, ASPIRE trial protocol and patient-facing materials. Each of the patient panellists currently use one of the approved therapies for IPF and 50% had previous clinical trial experience. Patient panellists were 61-80 years of age, 83% male, whereas the caregiver panellists were 71-80 years of age and female. Insights from the first interaction could be categorised into three PF core aspirations: Patient first, patient feedback, and promises fulfilled. These insights guided the design of the ASPIRE trial by minimizing site visits, adding virtual visits, optimizing communication material, and creating means to ensure continued participant feedback during trial. The ASPIRE trial aims to maximise trial attractiveness through continuous feedback from patients and caregivers. The three core aspirations continue to guide the conduct and reporting of ASPIRE through empowered trial participants.