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Purpose

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

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

Pulmonary Associates, PA
Mesa 5304391, Arizona 5551752 85206-1346
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Dignity Health Norton Thoracic Institute
Phoenix 5308655, Arizona 5551752 85013
Contact:
Daewoong Pharmaceutical, Co.,Ltd

The University of California San Francisco
San Francisco 5391959, California 5332921 94143
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Loyola University Medical Center (LUMC)
Maywood 4901514, Illinois 4896861 60153
Contact:
Daewoong Pharmaceutical, Co.,Ltd

University of Kansas Medical Center Research Institute, Inc
Kansas City 4273837, Kansas 4273857 66160
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Daewoong Pharmaceutical, Co.,Ltd

University of Michigan Health System
Michigan Center 5001813, Michigan 5001836 48109
Contact:
Daewoong Pharmaceutical, Co.,Ltd

The Lung Research Center, LLC
Chesterfield 4381072, Missouri 4398678 63017
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27705
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Pulmonix Research, LLC
Greensboro 4469146, North Carolina 4482348 27403
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Legacy Research Institute
Portland 5746545, Oregon 5744337 97232
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Penn State Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Daewoong Pharmaceutical, Co.,Ltd

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Daewoong Pharmaceutical, Co.,Ltd

The U.S. Department of Veterans Affairs
Charleston 4574324, South Carolina 4597040 29401
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Lowcountry Lung and Critical Care
Charleston 4574324, South Carolina 4597040 29406
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Baylor Scott & White Research Institute
Dallas 4684888, Texas 4736286 75204
Contact:
Daewoong Pharmaceutical, Co.,Ltd

The University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390-9020
Contact:
Daewoong Pharmaceutical, Co.,Ltd

Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Contact:
Daewoong Pharmaceutical, Co.,Ltd

The University of Texas Health San Antonio Medical Arts & Research Center
San Antonio 4726206, Texas 4736286 78229-3901
Contact:
Daewoong Pharmaceutical, Co.,Ltd

More Details

NCT ID
NCT05389215
Status
Recruiting
Sponsor
Daewoong Pharmaceutical Co. LTD.

Study Contact

YeaRa Kwak
+82-2-550-8010
yeara.kwak@daewoong.co.kr

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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