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

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

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
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, Arizona 85206-1346
Contact:
Daewoong Pharmaceutical, Co.,Ltd

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The University of Texas Health San Antonio Medical Arts & Research Center
San Antonio, Texas 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.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center