RecruitingPhase 2NCT05389215
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
Sponsor
Daewoong Pharmaceutical Co. LTD.
Enrollment
102 participants
Start Date
Jul 29, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 40 Years
Inclusion Criteria8
- 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 Criteria5
- 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
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Interventions
DRUGDWN12088
DWN12088 Xmg Tablet (BID)
DRUGPlacebo
Placebo 0mg Tablet (BID)
Locations(30)
View Full Details on ClinicalTrials.gov
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NCT05389215
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