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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389215
• Other study ID #: DW_DWN12088201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 29, 2022
• Est. completion date: December 19, 2025

Study information

• Verified date: April 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: YeaRa Kwak
• Phone: +82-2-550-8010
• Email: yeara.kwak[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 19, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• DWN12088
DWN12088 Xmg Tablet (BID)
• Placebo
Placebo 0mg Tablet (BID)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of decline of FVC	To investigate the efficacy of DWN12088 on pulmonary function	From Day 1 through Week 24
Primary	Incidents of treatment-emergent adverse events	To evaluate the safety and tolerability of DWN12088 compared with placebo	From Day 1 through Week 24
Secondary	Time to progression of IPF	To evaluate the efficacy of DWN12088 on time to progression of IPF	From Day 1 through Week 24
Secondary	Quantitative high-resolution computed tomography	To evaluate the efficacy of DWN12088 as measured by quantitative high-resolution computed tomography	From Day 1 through Week 24
Secondary	Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance	To evaluate the efficacy of DWN12088 on functional exercise capacity, assessed by 6MWT distance	From Day 1 through Week 24
Secondary	Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb	To evaluate the efficacy of DWN12088 on pulmonary diffusion function	From Day 1 through Week 24