Study to evaluate HZN-825 in patients with Idiopathic Pulmonary Fibrosis (IPF)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    360
  • sponsor
    Horizon Therapeutics Ireland DAC
Updated on 14 July 2022
pneumonia
emphysema
diffusion capacity of the lung for carbon monoxide

Summary

The goal is to determine the efficacy, safety and tolerability for 360 patients with Idiopathic Pulmonary Fibrosis (IPF) assigned to either one of 2 dose regimens of HZN-825 (administered once daily (QD) or twice daily (BID)) or a placebo regimen for 52 weeks. Participants who complete the duration of this trial may be eligible to enter an open-label 52-week extension trial where all patients will receive active HZN-825. Particpants not entering the extension will have a final follow-up visit for a final safety evaluation.

Description

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: Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no; FVC % predicted at Baseline: ≥70% or <70%.

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment Placebo, HZN-825
Clinical Study IdentifierNCT05032066
SponsorHorizon Therapeutics Ireland DAC
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Lung HRCT historically performed within 6 months prior to the Screening Visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT. If an evaluable HRCT is not available within 6 months prior to Screening, an HRCT will be performed at Screening to determine eligibility, according to the same requirements as the historical HRCT
Diagnosis of IPF, as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines [Raghu et al., 2018]; the date of diagnosis of IPF should be ≥1 year to ≤7 years prior to Screening
Meets all of the following criteria during the Screening Period: FVC ≥45% and ≤80% predicted of normal, forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, DLCO corrected for hemoglobin is ≥30% and ≤90% predicted of normal
Not currently being treated with specific IPF therapy for the reasons: intolerant or not responsive to approved IPF therapies; ineligible to receive approved IPF therapies; declines approved IPF therapies
HRCT shows ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing and the extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (central reviewer determined)

Exclusion Criteria

Any of the following cardiovascular diseases: uncontrolled, severe hypertension (≥160/100 mmHg), within 6 months of Screening; myocardial infarction within 6 months of Screening; unstable cardiac angina within 6 months of Screening
Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis and coronavirus disease 2019 [COVID-19]), connective tissue disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus, Sjogren's, dermatomyositis, scleroderma), exposures (e.g., radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone)
Use of any of the following therapies within 4 weeks prior to Screening, during the Screening Period or planned during the trial: prednisone at steady dose >10 mg/day or equivalent or cyclosporine A. Prednisone ≤10 mg/day (or equivalent dosing of glucocorticoids) is allowed
Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed). The subject must be 3 months beyond any acute infection with COVID-19 if there has been a prior infection
Clinically significant pulmonary hypertension requiring chronic medical therapy
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