NCT05389215
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
- YeaRa Kwak - Role: CONTACT - Phone: +82-2-550-8010 - Email: yeara.kwak@daewoong.co.kr
PHASE2
RECRUITING
NCT05389215
INTERVENTIONAL
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
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
Idiopathic Pulmonary Fibrosis
- TREATMENT
-
- Type: DRUG
- Name: DWN12088
- Description: DWN12088 Xmg Tablet (BID)
- Arm Group Labels: DWN12088 Xmg Tablet (BID)
-
- Type: DRUG
- Name: Placebo
- Description: Placebo 0mg Tablet (BID)
- Arm Group Labels: Placebo 0mg Tablet (BID)
- Daewoong Pharmaceutical Co. LTD.