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

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

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

• 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