🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05389215
Active, not recruiting Phase 2

Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF

NCT05389215 · tracked via the Priya Life Science USA tracker
Sponsor
Daewoong Pharmaceutical Co. LTD.
Phase
Phase 2
Started
2022-07-29
Last updated
2026-07-16

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

DWN12088Placebo

DWN12088: DWN12088 Xmg Tablet (BID)

Placebo: Placebo 0mg Tablet (BID)

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
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 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 * Meeting all of the following criteria during the screening period: * FVC ≥40% predicted of normal * DLCO corrected for Hgb ≥25% and ≤80% predicted of normal. * forced expiratory volume in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value Exclusion Criteria: * Acute IPF exacerbation within 6 months prior to screening and/or during the screening period * Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study * Female patients who are pregnant or nursing * Abnormal ECG findings * Use of any investigational drugs for IPF within 4 weeks prior to screening

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Pulmonary Associates, PA Mesa Arizona
Dignity Health Norton Thoracic Institute Phoenix Arizona
The University of California San Francisco San Francisco California
Loyola University Medical Center (LUMC) Maywood Illinois
University of Kansas Medical Center Research Institute, Inc Kansas City Kansas
Tufts Medical Center Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
University of Michigan Health System Michigan Center Michigan
The Lung Research Center, LLC Chesterfield Missouri
Duke University Medical Center Durham North Carolina
Pulmonix Research, LLC Greensboro North Carolina
Legacy Research Institute Portland Oregon
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
The U.S. Department of Veterans Affairs Charleston South Carolina
Lowcountry Lung and Critical Care Charleston South Carolina
Baylor Scott & White Research Institute Dallas Texas
The University of Texas Southwestern Medical Center Dallas Texas
Baylor College of Medicine Houston Texas
The University of Texas Health San Antonio Medical Arts & Research Center San Antonio Texas
Inje University Busan Paik Hospital Busan Busan
The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon-si Gyeonggi-do
Myongji Hospital Goyang-si Gyeonggi-do
Soon Chun Hyang University Hospital Bucheon Bucheon-si Gyeonggido
Ajou University Hospital Hwaseong-si Gyeonggido
Seoul National University Hospital Seoul Seoul
Severance Hospital, Yonsei University Health System Seoul Seoul
Asan Medical Center Seoul Seoul
Samsung Medical Center Seoul Seoul
Ulsan University Hospital Ulsan Ulsan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05389215 on ClinicalTrials.gov ↗ ← All trials in the USA