NCT05389215 · Daewoong Pharmaceutical Co. LTD.
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
What this study is about
This is a randomly assigned, double-blinded, compared against an inactive treatment conducted at multiple hospitals study to evaluate the safety and effectiveness of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
View original scientific description
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Interventions
DRUG
DWN12088
DWN12088 Xmg Tablet (BID)
DRUG
Placebo
Placebo 0mg Tablet (BID)
Primary outcome measures
Rate of decline of FVC
Time frame: From Day 1 through Week 24
To investigate the efficacy of DWN12088 on pulmonary function
Incidents of treatment-emergent adverse events
Time frame: From Day 1 through Week 24
To evaluate the safety and tolerability of DWN12088 compared with placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Mesa, Arizona
- Phoenix, Arizona
- San Francisco, California
- Maywood, Illinois
- Kansas City, Kansas
- Boston, Massachusetts
- Michigan Center, Michigan
- Chesterfield, Missouri
- Durham, North Carolina
- Greensboro, North Carolina
- Portland, Oregon
- Hershey, Pennsylvania
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2025 · Source of record for eligibility and locations