A phase II investigator-initiated clinical trial of PAI-1 inhibitor (TM5614) for systemic sclerosis-associated interstitial lung disease under immunosuppressive treatment

Asano Yoshihide0 sites50 target enrollmentSeptember 6, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 6, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

Asano Yoshihide

•1\. Patients 18 years of age or older with written consent
•2\. Patients with systemic sclerosis who meet the 2013 ACR/EULAR classification criteria for systemic sclerosis
•3\. Within 7 years of the onset of systemic sclerosis (first appearance of systemic sclerosis\-related symptoms other than Raynaud's phenomenon)
•4\. Interstitial lung disease associated with systemic sclerosis confirmed by high\-resolution CT performed within 12 months, and lung involvement greater than 10% in extent
•5\. %FVC of 40% or more
•6\. %DLco of 30% or more but less than 90%
•7\. No oral administration of PSL 10 mg/day or more within 2 weeks prior to obtaining consent (less than 10 mg/day during the study period, dose cannot be increased)
•8\. No treatment with antifibrotic drugs or tocilizumab within 4 weeks
•9\. Not receiving rituximab treatment within 6 months
•10\. Receiving immunosuppressive drugs (azathioprine, cyclophosphamide, or mycophenolate mofetil) at least 6 months prior to the date of consent, mycophenolate mofetil at least 3 months prior to the date of consent, and no dose change of mycophenolate mofetil within 3 months

•1\. Patients with an estimated right ventricular systolic pressure greater than 35 mmHg on echocardiography performed within 12 months prior to enrollment, or with pulmonary arterial hypertension requiring treatment
•2\. Patients with FEV1/FVC less than 0\.7
•3\. Patients with AST, ALT, or bilirubin exceeding 1\.5 times the upper limit of the institutional reference value
•4\. Patients with creatinine clearance (Cockcroft\-Gault method) less than 30 mL/min
•5\. Patients with poorly controlled hypertension (systolic pressure of 160 mmHg or more, or diastolic pressure of 100 mmHg or more)
•6\. Patients with a history of myocardial infarction or unstable angina pectoris within 6 months prior to obtaining consent
•7\. Patients with chronic liver failure
•8\. Patients with a history of serious trauma or surgery within 3 months prior to consent
•9\. Patients on anticoagulation therapy
•10\. Patients receiving more than 3 antiplatelet agents