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

Purpose

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

Condition

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
DWN12088 Xmg Tablet (BID) 		PRS inhibitor
  • Drug: DWN12088
    DWN12088 Xmg Tablet (BID)
    Other names:
    • DWN12088 Xmg Tablet (BID)
Placebo Comparator
Placebo 0mg Tablet (BID) 		Placebo
  • Drug: Placebo
    Placebo 0mg Tablet (BID)
    Other names:
    • Placebo 0mg Tablet (BID)

Recruiting Locations

University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas 66160
Contact:
Daewoong Pharmaceutical, Co.,Ltd

More Details

Status
Recruiting
Sponsor
Daewoong Pharmaceutical Co. LTD.

Study Contact

YeaRa Kwak
+82-2-550-8010
yeara.kwak@daewoong.co.kr

Detailed Description

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