A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2023-10-01

Summary

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in subjects with IPF. Subjects will be screened within 8 weeks prior to the Baseline (Day 1) Visit. Approximately 360 subjects who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks using the following 2 stratification factors:

1. Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no

2. FVC % predicted at Baseline: ≥70% or <70%

• Phase: Phase 2

Details

• Lead Sponsor: Horizon Therapeutics Ireland DAC