Actively Recruiting

Phase 2
Age: 40Years +
All Genders
NCT05389215

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

Led by Daewoong Pharmaceutical Co. LTD. · Updated on 2025-08-05

102

Participants Needed

30

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 240 years or older
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) by recognized guidelines
  • Stable condition suitable for participation based on medical history, physical exam, vital signs, ECG, and labs
  • Receiving stable doses of pirfenidone or nintedanib for at least 3 months prior or not receiving these treatments
  • Lung function criteria during screening: FVC 240% predicted or higher, DLCO corrected for hemoglobin between 25% and 80% predicted, and FEV1/FVC ratio of 0.7 or higher based on pre-bronchodilator value
Not Eligible

You will not qualify if you...

  • Acute exacerbation of IPF within 6 months before or during screening
  • Unwillingness to stop smoking 3 months before screening and during the study
  • Pregnant or nursing women
  • Abnormal ECG findings
  • Use of investigational drugs for IPF within 4 weeks prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

Pulmonary Associates, PA

Mesa, Arizona, United States, 85206-1346

Actively Recruiting

2

Dignity Health Norton Thoracic Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

3

The University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

4

Loyola University Medical Center (LUMC)

Maywood, Illinois, United States, 60153

Actively Recruiting

5

University of Kansas Medical Center Research Institute, Inc

Kansas City, Kansas, United States, 66160

Actively Recruiting

6

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

7

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

8

University of Michigan Health System

Michigan Center, Michigan, United States, 48109

Actively Recruiting

9

The Lung Research Center, LLC

Chesterfield, Missouri, United States, 63017

Actively Recruiting

10

Duke University Medical Center

Durham, North Carolina, United States, 27705

Actively Recruiting

11

Pulmonix Research, LLC

Greensboro, North Carolina, United States, 27403

Actively Recruiting

12

Legacy Research Institute

Portland, Oregon, United States, 97232

Actively Recruiting

13

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

14

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

15

The U.S. Department of Veterans Affairs

Charleston, South Carolina, United States, 29401

Actively Recruiting

16

Lowcountry Lung and Critical Care

Charleston, South Carolina, United States, 29406

Actively Recruiting

17

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75204

Actively Recruiting

18

The University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390-9020

Actively Recruiting

19

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

20

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

San Antonio, Texas, United States, 78229-3901

Actively Recruiting

21

Inje University Busan Paik Hospital

Busan, Busan, South Korea, 47392

Actively Recruiting

22

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea, 14647

Actively Recruiting

23

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea, 10475

Actively Recruiting

24

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggido, South Korea, 14584

Actively Recruiting

25

Ajou University Hospital

Hwaseong-si, Gyeonggido, South Korea, 16499

Actively Recruiting

26

Seoul National University Hospital

Seoul, Seoul, South Korea, 03080

Actively Recruiting

27

Severance Hospital, Yonsei University Health System

Seoul, Seoul, South Korea, 03722

Actively Recruiting

28

Asan Medical Center

Seoul, Seoul, South Korea, 05505

Actively Recruiting

29

Samsung Medical Center

Seoul, Seoul, South Korea, 06351

Actively Recruiting

30

Ulsan University Hospital

Ulsan, Ulsan, South Korea, 44033

Actively Recruiting

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Research Team

Y

YeaRa Kwak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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