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

April 16, 2024 updated by: Daewoong Pharmaceutical Co. LTD.

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From Day 1 through Week 24
To investigate the efficacy of DWN12088 on pulmonary function
From Day 1 through Week 24
Incidents of treatment-emergent adverse events
Time Frame: From Day 1 through Week 24
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
Time Frame: From Day 1 through Week 24
To evaluate the efficacy of DWN12088 on time to progression of IPF
From Day 1 through Week 24
Quantitative high-resolution computed tomography
Time Frame: From Day 1 through Week 24
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
Time Frame: From Day 1 through Week 24
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
Time Frame: From Day 1 through Week 24
To evaluate the efficacy of DWN12088 on pulmonary diffusion function
From Day 1 through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Song, AIDS Malignancy Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 19, 2025

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)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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