This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with IPF with or without standard-of-care. Patients meeting the eligibility criteria for the study will be randomized with a 2:1 ratio to DWN12088 150 mg BID or the matching placebo. Randomization will be stratified according to other medications for IPF (patients receiving pirfenidone or nintedanib and patients with no treatment for IPF, with a minimum of 30% of patients on no treatment) and to country (patients in United States or South Korea). Patients will receive study treatment for 24 weeks. The patients will visit the clinical study site at screening (Day -56 to Day 0), Day 1 (baseline), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 18 (Day 126), Week 24 (Day 168), and Week 28 (Day 196) or the end-of-treatment (EOT) visit.
Daewoong IPF study
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
Pulmonary fibrosis
All genders
40-100
Recruiting now
Overview
Principal Investigator: Nicholas Hill, MD
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Bipin Malla
Study details
Inclusion Criteria
- 1) Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2018 guidelines within the past 5 years prior to study participation.
- 2) Chest HRCT performed within 12 months prior to screening and with centrally confirmed HRCT pattern of usual interstitial pneumonia or specific combinations of HRCT patterns and histopathology patterns in patients whose lung biopsy slides are available for central review. If no HRCT is available prior to screening, an HRCT can be performed at screening.
- 3) Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib. If the patients were on pirfenidone or nintedanib previously and have been off for at least 3 months prior to screening, they will be considered as not on any treatment for IPF
Exclusion Criteria
- 1) Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
- 2) Sustained improvement in the severity of IPF in FVC and exercise capacity(investigator-determined).
- 3) Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
Study Requirements
There will be at least nine clinic visits during the study in a span of about 30 weeks. Visits will include but not limited to, two high resolution CT-scan of chest, multiple Pulmonary function test, ECG, blood draws and six minute walk tests. Total amount of blood draw is about 170.4 ml during the entire study period.