Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF

Study Overview
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Brief Summary
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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
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This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: DWN12088
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWN12088 Xmg Tablet (BID)<br>PRS inhibitor | Drug: DWN12088<br>* DWN12088 Xmg Tablet (BID)<br>* Other names: DWN12088 Xmg Tablet (BID);|
| Placebo Comparator: Placebo 0mg Tablet (BID)<br>Placebo | Drug: Placebo<br>* Placebo 0mg Tablet (BID)<br>* Other names: Placebo 0mg Tablet (BID);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline of FVC | To investigate the efficacy of DWN12088 on pulmonary function | From Day 1 through Week 24 | 
| Incidents of treatment-emergent adverse events | To evaluate the safety and tolerability of DWN12088 compared with placebo | From Day 1 through Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression of IPF | To evaluate the efficacy of DWN12088 on time to progression of IPF | 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 | 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 | 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 | From Day 1 through Week 24 |