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

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: DWN12088; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05389215

DW_DWN12088201

Details and patient eligibility

About

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

Full description

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

Enrollment: 102 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

DWN12088 Xmg Tablet (BID)

Experimental group

Description:

PRS inhibitor

Treatment:

Drug: DWN12088

Placebo 0mg Tablet (BID)

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo