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NCT05389215

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

Active, Not Recruiting
PHASE2Ages 40+InterventionalTreatment
Daewoong Pharmaceutical Co. LTD.
~102 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:DWN12088Placebo

At a glance

Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of decline of FVC
Measured over From Day 1 through Week 24
+1 more outcome measured

Conditions

Idiopathic Pulmonary Fibrosis

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Idiopathic Pulmonary Fibrosis

NCT05389215

Where you'd take part

This study runs at 30 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ajou University Hospital

    Hwaseong-si, Gyeonggido, South Koreano site contact published

  • Asan Medical Center

    Seoul, Seoul, South Koreano site contact published

  • Baylor College of Medicine

    Houston, Texasno site contact published

  • Baylor Scott & White Research Institute

    Dallas, Texasno site contact published

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

  • Dignity Health Norton Thoracic Institute

    Phoenix, Arizonano site contact published

  • Duke University Medical Center

    Durham, North Carolinano site contact published

  • Inje University Busan Paik Hospital

    Busan, Busan, South Koreano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Song · PRINCIPAL_INVESTIGATOR · AIDS Malignancy Consortium

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of decline of FVCFrom Day 1 through Week 24

    To investigate the efficacy of DWN12088 on pulmonary function

  • Incidents of treatment-emergent adverse eventsFrom Day 1 through Week 24

    To evaluate the safety and tolerability of DWN12088 compared with placebo