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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • DWN12088
  • Placebo

Treatment groups

102 Participants
are divided into 2 treatment groups