Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGDWN12088
DWN12088 Xmg Tablet (BID)
DRUGPlacebo
Placebo 0mg Tablet (BID)
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea, United States
Contacts
PRINCIPAL_INVESTIGATORSong
AIDS Malignancy Consortium
Outcome results
None listed