Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.

Official Title
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Phase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: ART-123
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Patients diagnosed with IPF who meet all criteria from (1) through (4) during the course of IPF (1)Unexplained development or worsening of dyspnea within 1 month during the course of IPF (2)Finding of new, bilateral ground glass opacities and/or consolidation on HRCT (3)No apparent Pulmonary infections, pneumothorax, malignant tumors, pulmonary embolism, or left heart failure (4)A decrease* in PaO2 of ≥10 mmHg or SpO2 of ≥4% under the same conditions compared with the level at the previous measurements (*) In cases where no PaO2 or SpO2 test values under the same conditions are available, a patient with a P/F ratio ≤300 in the current episode of acute exacerbation is considered to have met criterion (4) Aged 40 years or older and no older than 85 years at the time of informed consent with either sex Main Exclusion Criteria: Have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding (continued hematemesis, bloody discharge, gastrointestinal ulcer-induced hemorrhage) Have a history of cerebrovascular disorder (e.g., cerebral hemorrhage or cerebral infarction) within 52 weeks (364 days) before informed consent Patients for whom the completion of hemostatic treatment has not been confirmed after undergoing surgery of the central nervous system or after trauma Have a high risk for fatal or life-threatening hemorrhage Patients with malignant tumors Have acute exacerbation attributable to drug induced pulmonary disorder, after surgery for malignant tumors, chemotherapy, or radiation therapy Have acute exacerbation due to a thoracic surgical procedure (including thoracoscopic lung biopsy) Have a history of acute exacerbation of IPF Receiving mechanical ventilation through intratracheal intubation Patients who are pregnant or nursing, or who may be pregnant Patients with a platelet count less than 100,000/uL at the time of enrollment Patients with severe renal (serum Cr: ≥4 mg/dL) or hepatic (AST/ALT: ≥500 IU/L or T-Bil: ≥10 mg/dL) dysfunction Have been administered a commercially available thrombomodulin alfa (recombinant )(Recomodulin® for Intravenous Injection 12800) within 30 days before the start of investigational product administration Have a history of hypersensitivity for investigational product

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ART-123<br> | Drug: ART-123<br>* 380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo by intravenous drip infusion in addition to standard of care steroid therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate on Day 90 |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 180 days after the start of investigational product administration in the last subject | 
| Survival time up to Day 90 |  | 90days | 
| P/F ratio |  | 4 days, 7 days, 15 days, 28 days, 60 days, 90 days | 
| Coagulation tests |  | 4 days, 7 days, 15days, 28 days, 60 days, 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute exacerbations, Idiopathic pulmonary fibrosis, Recombinant human soluble thrombomodulin, ART-123