Clinical trial NCT05389215: Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of decline of FVC
timeFrame: From Day 1 through Week 24
measure: Incidents of treatment-emergent adverse events
timeFrame: From Day 1 through Week 24
Secondary outcomes:
measure: Time to progression of IPF
timeFrame: From Day 1 through Week 24
measure: Quantitative high-resolution computed tomography
timeFrame: From Day 1 through Week 24
measure: Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance
timeFrame: From Day 1 through Week 24
measure: Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb
timeFrame: From Day 1 through Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health Norton Thoracic Institute
state: Arizona
city: San Francisco
country: United States
facility: The University of California San Francisco
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center (LUMC)
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Michigan Center
country: United States
facility: University of Michigan Health System
state: Michigan
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Pulmonix Research, LLC
state: North Carolina
city: Portland
country: United States
facility: Legacy Research Institute
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: The U.S. Department of Veterans Affairs
state: South Carolina
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health San Antonio Medical Arts & Research Center
state: Texas
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeonggido
city: Hwaseong-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: AIDS Malignancy Consortium
name: Song
role: PRINCIPAL_INVESTIGATOR
References: