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

Phase 2

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: DWN12088; Drug: Placebo

• Registration Number: NCT05389215
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Study Timeline

• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Study Start: 2022-07-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWN12088 Xmg Tablet (BID)	DWN12088	PRS inhibitor
Placebo 0mg Tablet (BID)	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (30)

Pulmonary Associates, PA; 🇺🇸 Mesa, Arizona, United States

Dignity Health Norton Thoracic Institute; 🇺🇸 Phoenix, Arizona, United States

The University of California San Francisco; 🇺🇸 San Francisco, California, United States

Loyola University Medical Center (LUMC); 🇺🇸 Maywood, Illinois, United States

University of Kansas Medical Center Research Institute, Inc; 🇺🇸 Kansas City, Kansas, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Health System; 🇺🇸 Michigan Center, Michigan, United States

The Lung Research Center, LLC; 🇺🇸 Chesterfield, Missouri, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

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