RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-07-29

Study Completion:2025-12-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05389215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

YeaRa Kwak

CONTACT

+82-2-550-8010

yeara.kwak@daewoong.co.kr

Principal Investigator

Song

PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Study Locations (Sites)

Pulmonary Associates, PA

Mesa, Arizona, 85206-1346

United States

Dignity Health Norton Thoracic Institute

Phoenix, Arizona, 85013

United States

The University of California San Francisco

San Francisco, California, 94143

United States

Loyola University Medical Center (LUMC)

Maywood, Illinois, 60153

United States

University of Kansas Medical Center Research Institute, Inc

Kansas City, Kansas, 66160

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of Michigan Health System

Michigan Center, Michigan, 48109

United States

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

United States

Duke University Medical Center

Durham, North Carolina, 27705

United States

Pulmonix Research, LLC

Greensboro, North Carolina, 27403

United States

Legacy Research Institute

Portland, Oregon, 97232

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

The U.S. Department of Veterans Affairs

Charleston, South Carolina, 29401

United States

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406

United States

Baylor Scott & White Research Institute

Dallas, Texas, 75204

United States

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9020

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

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

San Antonio, Texas, 78229-3901

United States

Collaborators and Investigators

Sponsor: Daewoong Pharmaceutical Co. LTD.

Song, PRINCIPAL_INVESTIGATOR, AIDS Malignancy Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-29

Study Completion Date2025-12-19

Study Record Updates

Study Start Date2022-07-29

Study Completion Date2025-12-19

Terms related to this study

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis