A randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the efficacy and safety of 2 doses of buloxibutid over 52 weeks in people with idiopathic pulmonary fibrosis (ASPIRE (VP-C21-011))

Research summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of orally administered buloxibutid, either as monotherapy or on top of stable IPF therapy, are assessed in participants with IPF. The trial will include participants who are on stable licensed IPF therapy or who are currently not treated with a licensed IPF therapy. The latter group will include participants intolerant or not responsive to licensed IPF therapies, participants ineligible to receive these therapies and participants who have voluntarily declined to receive a licensed IPF therapy after being fully informed of the potential benefits and risks of such therapy. Due to the risk of drug-drug interactions (DDIs), concomitant treatment with pirfenidone is not allowed in this trial. Randomization will be stratified based on use of licensed IPF therapy and FVCpp (<60, ≥60 and ≤80, >80% predicted). Participants not using licensed IPF therapy should comprise at least 30% of the trial population. The trial is planned to enroll 270 participants, 90 participants on oral buloxibutid 50 mg BID, 90 participants on oral buloxibutid 100 mg BID, and 90 participants on oral placebo BID for 52 weeks.

Principal Investigator

Dr Peter Saunders

Contact us

Email: samantha.chilcott@ndm.ox.ac.uk

IRAS number

1009572