Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Purpose
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DWN12088 Xmg Tablet (BID) |
PRS inhibitor |
|
|
Placebo Comparator Placebo 0mg Tablet (BID) |
Placebo |
|
Recruiting Locations
The University of Texas Health San Antonio Medical Arts & Research Center
San Antonio, Texas 78229-3901
San Antonio, Texas 78229-3901
Contact:
Daewoong Pharmaceutical, Co.,Ltd
Daewoong Pharmaceutical, Co.,Ltd
More Details
- Status
- Recruiting
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
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.