Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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

Details

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

Keywords

Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, DWN12088, DWN12088 Xmg Tablet (BID)

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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 CAN'T join 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

Locations

  • The UCSF accepting new patients
    San Francisco California 94143 United States
  • Dignity Health Norton Thoracic Institute accepting new patients
    Phoenix Arizona 85013 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daewoong Pharmaceutical Co. LTD.
ID
NCT05389215
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 102 study participants
Last Updated