DWN12088 in Patients With IPF

This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with idiopathic pulmonary fibrosis.

  • Study Sponsor: Daewoong Pharmaceutical Co. LTD.

  • Start Date: July 2022

  • Estimated Primary Completion Date: September 2025

  • Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of DWN12088 in patients with idiopathic pulmonary fibrosis.

Primary Outcome Measure:

  • Rate of decline of FVC [Timeframe: from day 1 through week 24]
  • Incidents of treatment-emergent adverse events [Timeframe: from day 1 through week 24]

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.

Participating Clinics at Partner ILD Centers

BIDMC ILD Clinic