This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
Rate of decline of FVC
To investigate the efficacy of DWN12088 on pulmonary function
Time frame: From Day 1 through Week 24
Incidents of treatment-emergent adverse events
To evaluate the safety and tolerability of DWN12088 compared with placebo
Time frame: From Day 1 through Week 24
Time to progression of IPF
To evaluate the efficacy of DWN12088 on time to progression of IPF
Time frame: From Day 1 through Week 24
Quantitative high-resolution computed tomography
To evaluate the efficacy of DWN12088 as measured by quantitative high-resolution computed tomography
Time frame: From Day 1 through Week 24
Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance
To evaluate the efficacy of DWN12088 on functional exercise capacity, assessed by 6MWT distance
Time frame: From Day 1 through Week 24
Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb
To evaluate the efficacy of DWN12088 on pulmonary diffusion function
Time frame: From Day 1 through Week 24
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