A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
Daewoong Pharmaceutical Co. LTD.
Summary
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Description
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patients aged ≥40 years based on the date of the written informed consent form * Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines * In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation * Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior…
Interventions
- DrugDWN12088
DWN12088 Xmg Tablet (BID)
- DrugPlacebo
Placebo 0mg Tablet (BID)
Locations (30)
- Pulmonary Associates, PAMesa, Arizona
- Dignity Health Norton Thoracic InstitutePhoenix, Arizona
- The University of California San FranciscoSan Francisco, California
- Loyola University Medical Center (LUMC)Maywood, Illinois
- University of Kansas Medical Center Research Institute, IncKansas City, Kansas
- Tufts Medical CenterBoston, Massachusetts