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Evaluating DWN12088 for treating Idiopathic Pulmonary Fibrosis

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

Phase 2 Interventional Daewoong Pharmaceutical Co. LTD. · NCT05389215

This study is testing a new drug called DWN12088 to see if it can safely help people with Idiopathic Pulmonary Fibrosis feel better compared to those who receive a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment102 (estimated)
Ages40 Years and up
SexAll
SponsorDaewoong Pharmaceutical Co. LTD. Industry-sponsored
Locations30 sites (Mesa, Arizona and 29 other locations)
Trial IDNCT05389215 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blinded, placebo-controlled multicenter evaluation of DWN12088, aimed at assessing its safety and efficacy in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF). Participants will be monitored for their response to the treatment compared to a placebo group. The study includes patients who are either on standard care for IPF or have not received treatment for at least three months prior to screening. The trial will involve multiple locations to gather diverse data on the drug's performance.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of IPF who are stable and meet specific lung function criteria.

Not a fit: Patients with severe IPF or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Idiopathic Pulmonary Fibrosis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for IPF.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Mesa, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.