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Clinical Trial 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%

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05032066
Study type Interventional
Source Horizon Pharma Ireland, Ltd., Dublin Ireland
Contact Horizon Therapeutics
Phone 866-479-6742
Email [email protected]
Status Recruiting
Phase Phase 2
Start date August 25, 2021
Completion date October 2023

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