Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
- Registration Number
- NCT05389215
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief 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.
- Detailed Description
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DWN12088 Xmg Tablet (BID) DWN12088 PRS inhibitor Placebo 0mg Tablet (BID) Placebo Placebo
- Primary Outcome Measures
Name Time Method Rate of decline of FVC From Day 1 through Week 24 To investigate the efficacy of DWN12088 on pulmonary function
Incidents of treatment-emergent adverse events From Day 1 through Week 24 To evaluate the safety and tolerability of DWN12088 compared with placebo
- Secondary Outcome Measures
Name Time Method Time to progression of IPF From Day 1 through Week 24 To evaluate the efficacy of DWN12088 on time to progression of IPF
Quantitative high-resolution computed tomography From Day 1 through Week 24 To evaluate the efficacy of DWN12088 as measured by quantitative high-resolution computed tomography
Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance From Day 1 through Week 24 To evaluate the efficacy of DWN12088 on functional exercise capacity, assessed by 6MWT distance
Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb From Day 1 through Week 24 To evaluate the efficacy of DWN12088 on pulmonary diffusion function
Trial Locations
- Locations (30)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The Catholic University of Korea, Bucheon St. Mary's Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Lowcountry Lung and Critical Care
🇺🇸Charleston, South Carolina, United States
Ajou University Hospital
🇰🇷Hwaseong-si, Gyeonggido, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Gyeonggido, Korea, Republic of
The U.S. Department of Veterans Affairs
🇺🇸Charleston, South Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The University of Texas Health San Antonio Medical Arts & Research Center
🇺🇸San Antonio, Texas, United States
University of Kansas Medical Center Research Institute, Inc
🇺🇸Kansas City, Kansas, United States
The University of California San Francisco
🇺🇸San Francisco, California, United States
Dignity Health Norton Thoracic Institute
🇺🇸Phoenix, Arizona, United States
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Pulmonary Associates, PA
🇺🇸Mesa, Arizona, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Pulmonix Research, LLC
🇺🇸Greensboro, North Carolina, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Myongji Hospital
🇰🇷Goyang, Gyeonggi, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Loyola University Medical Center (LUMC)
🇺🇸Maywood, Illinois, United States
University of Michigan Health System
🇺🇸Michigan Center, Michigan, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Legacy Research Institute
🇺🇸Portland, Oregon, United States