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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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

Key facts

Study ID

NCT05389215

Run by

Daewoong Pharmaceutical Co. LTD.

People needed

102

Starts

2022-07-29

Expected to finish

2027-01-30

Last updated by the study team

2026-07-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates, PA — Mesa, Arizona, United States
• Dignity Health Norton Thoracic Institute — Phoenix, Arizona, United States
• The University of California San Francisco — San Francisco, California, United States
• Loyola University Medical Center (LUMC) — Maywood, Illinois, United States
• University of Kansas Medical Center Research Institute, Inc — Kansas City, Kansas, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Michigan Center, Michigan, United States
• The Lung Research Center, LLC — Chesterfield, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Pulmonix Research, LLC — Greensboro, North Carolina, United States
• Legacy Research Institute — Portland, Oregon, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The U.S. Department of Veterans Affairs — Charleston, South Carolina, United States
• Lowcountry Lung and Critical Care — Charleston, South Carolina, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• The University of Texas Health San Antonio Medical Arts & Research Center — San Antonio, Texas, United States
• Inje University Busan Paik Hospital — Busan, Busan, South Korea
• The Catholic University of Korea, Bucheon St. Mary's Hospital — Bucheon-si, Gyeonggi-do, South Korea
• Myongji Hospital — Goyang-si, Gyeonggi-do, South Korea
• Soon Chun Hyang University Hospital Bucheon — Bucheon-si, Gyeonggido, South Korea
• Ajou University Hospital — Hwaseong-si, Gyeonggido, South Korea

Full record on ClinicalTrials.gov

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