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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: DWN12088; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Korea
  • Busan
    • Busan, Busan, South Korea, 47392
      • Inje University Busan Paik Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea, 14647
      • The Catholic University of Korea, Bucheon ST. Mary's Hospital
    • Goyang-si, Gyeonggi-do, South Korea, 10475
      • Myongji Hospital
  • Gyeonggido
    • Bucheon-si, Gyeonggido, South Korea, 14584
      • Soon Chun Hyang University Hospital Bucheon
    • Hwaseong-si, Gyeonggido, South Korea, 16499
      • Ajou University Hospital
  • Seoul
    • Seoul, Seoul, South Korea, 03080
      • Seoul National University Hospital
    • Seoul, Seoul, South Korea, 05505
      • Asan Medical Center
    • Seoul, Seoul, South Korea, 06351
      • Samsung Medical Center
    • Seoul, Seoul, South Korea, 03722
      • Severance Hospital, Yonsei University Health System
  • Ulsan
    • Ulsan, Ulsan, South Korea, 44033
      • Ulsan University Hospital
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206-1346
      • Pulmonary Associates, PA
    • Phoenix, Arizona, United States, 85013
      • Dignity Health Norton Thoracic Institute
  • California
    • San Francisco, California, United States, 94143
      • The University of California San Francisco
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center (LUMC)
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Michigan Center, Michigan, United States, 48109
      • University of Michigan Health System
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Lung Research Center, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27403
      • Pulmonix Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97232
      • Legacy Research Institute
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care
    • Charleston, South Carolina, United States, 29401
      • The U.S. Department of Veterans Affairs
  • Texas
    • Dallas, Texas, United States, 75204
      • Baylor Scott & White Research Institute
    • Dallas, Texas, United States, 75390-9020
      • The University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229-3901
      • The University of Texas Health San Antonio Medical Arts & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWN12088 Xmg Tablet (BID); PRS inhibitor	Drug: DWN12088; DWN12088 Xmg Tablet (BID); Other Names: DWN12088 Xmg Tablet (BID)
Placebo Comparator: Placebo 0mg Tablet (BID); Placebo	Drug: Placebo; Placebo 0mg Tablet (BID); Other Names: Placebo 0mg Tablet (BID)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Song, AIDS Malignancy Consortium

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Pharmaceutical Preparations; Dosage Forms; Tablets; BID protein, human
• Other Study ID Numbers: DW_DWN12088201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No