Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
102
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
August 5, 2025
July 1, 2025
4.2 years
April 17, 2022
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of decline of FVC
To investigate the efficacy of DWN12088 on pulmonary function
From Day 1 through Week 24
Incidents of treatment-emergent adverse events
To evaluate the safety and tolerability of DWN12088 compared with placebo
From Day 1 through Week 24
Secondary Outcomes (4)
Time to progression of IPF
From Day 1 through Week 24
Quantitative high-resolution computed tomography
From Day 1 through Week 24
Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance
From Day 1 through Week 24
Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb
From Day 1 through Week 24
Study Arms (2)
DWN12088 Xmg Tablet (BID)
EXPERIMENTALPRS inhibitor
Placebo 0mg Tablet (BID)
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Pulmonary Associates, PA
Mesa, Arizona, 85206-1346, United States
Dignity Health Norton Thoracic Institute
Phoenix, Arizona, 85013, United States
The University of California San Francisco
San Francisco, California, 94143, United States
Loyola University Medical Center (LUMC)
Maywood, Illinois, 60153, United States
University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, 66160, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Michigan Center, Michigan, 48109, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Pulmonix Research, LLC
Greensboro, North Carolina, 27403, United States
Legacy Research Institute
Portland, Oregon, 97232, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
The U.S. Department of Veterans Affairs
Charleston, South Carolina, 29401, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9020, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Texas Health San Antonio Medical Arts & Research Center
San Antonio, Texas, 78229-3901, United States
Inje University Busan Paik Hospital
Busan, Busan, 47392, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggido, 14584, South Korea
Ajou University Hospital
Hwaseong-si, Gyeonggido, 16499, South Korea
Seoul National University Hospital
Seoul, Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul, 03722, South Korea
Asan Medical Center
Seoul, Seoul, 05505, South Korea
Samsung Medical Center
Seoul, Seoul, 06351, South Korea
Ulsan University Hospital
Ulsan, Ulsan, 44033, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Song
AIDS Malignancy Consortium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2022
First Posted
May 25, 2022
Study Start
July 29, 2022
Primary Completion (Estimated)
October 13, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share