Status:
RECRUITING
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05389215
Start Date
July 29 2022
End Date
January 30 2027
Last Update
August 5 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Pulmonary Associates, PA
Mesa, Arizona, United States, 85206-1346
2
Dignity Health Norton Thoracic Institute
Phoenix, Arizona, United States, 85013
3
The University of California San Francisco
San Francisco, California, United States, 94143
4
Loyola University Medical Center (LUMC)
Maywood, Illinois, United States, 60153