fibrosing interstitial lung disease
Conditions
Interventions
Treatment group 1:SOC (corticosteroids) + Butaselen tablets (450mg)
administered twice daily (b.i.d.), orally, until the withdrawal criteria are met or treatment is completed for 24 weeks.
Treatment group 3:Butaselen tablets (600mg)
Placebo group 1:SOC (corticosteroids) + Placebo
Placebo group 2:Placebo
Treatment group 2:SOC (corticosteroids) + Butaselen tablets (600mg)
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Both sexes, aged 18-80 years (inclusive), and written informed consent provided at the time of signing; 2.Disease and conditions: (1) Diagnosed with fibrotic interstitial lung diseases (F-ILDs) [mainly including non-IPF idiopathic interstitial pneumonias (nonIPF-IIP) (such as idiopathic non-specific interstitial pneumonia (iNSIP), cryptogenic organizing pneumonia (COP), desquamative interstitial pneumonia (DIP), unclassifiable idiopathic interstitial pneumonia (U-IIP)), chronic hypersensitivity pneumonitis (CHP), interstitial pneumonia with autoimmune features (IPAF), chronic eosinophilic pneumonia (CEP), sarcoidosis] for >= 2 months; and with findings of 1) and/or 2) as follows: 1) Fibrosing lung disease affecting greater than 10% of total lung volume on high-resolution computed tomography (HRCT), with radiographic features including: interlobular septal thickening, reticular opacities, traction bronchiectasis/bronchiolectasis, lung structure distortion, honeycombing, with or without ground-glass opacity; 2) Histopathological findings of fibrosis through lung biopsy [transbronchial lung biopsy (TBLB) / transbronchial lung cryobiopsy (TBLC) / video-assisted thoracoscopic surgery (VATS)] including: alveolar septal or interlobular septal widening, fibroblast proliferation, collagen deposition, bronchiolectasis, honeycombing, and lung structure distortion; (2)Forced vital capacity (FVC) >=45% of predicted value and =40% of predicted value at screening and baseline; 3.The participants (including male) do not plan of pregnancy, also who will use effective contraception voluntarily, and do not donate sperm or eggs during the entire period of screening and the trial (details in Appendix 2); 4.For participants with fibrotic interstitial lung disease receiving corticosteroid therapy as background treatment, they should be treatment-naïve or have previously received conventional regimens (initial dose of prednisone 0.5-0.75 mg/kg/day (20-60 mg/day) or equivalent), and the investigator confirms their ability to adhere to the protocol-specified corticosteroid tapering regimen; 5.The participants understand the procedures and details of this trial and take part in the trial voluntarily with written informed consent; the participants will comply completely with the indications in the trial.
Exclusion criteria
Exclusion criteria: 1.Allergics, or known allergic history to ingredients in investigational product, and who are not appropriate for the trial as judged by clinical investigator. 2.Diagnosed of connective tissue disease-related interstitial lung disease(CTD-ILD), vasculitis-related interstitial lung disease, idiopathic pulmonary fibrosis (IPF). 3.Arterial partial pressure of oxygen (PaO2) =1 month; nintedanib 100-150 mg, b.i.d, for >=1 month); or antioxidant therapy (acetylcysteine 0.6 g, t.i.d, for >=1 month) within 1 month prior to screening. 8.Started standard immunosuppressive therapy (excluding glucocorticoids) including, but not limited to, cyclophosphamide, azathioprine, methotrexate, cyclosporine, tacrolimus, merti-macrolide, and tolizumab within 1 month prior to screening; rituximab within 6 months. 9.Have received (pathogenecity attenuated) live vaccine within 12 weeks prior to the first dose or plan to receive any (pathogenecity attenuated) live vaccine during the study period (except those who have received SARS-CoV-2 vaccine or vaccine booster for >=4 weeks). 10.The participant will be excluded with any disease condition or history as in followings: (1).the participant is unable to take the drug orally or has noticeable gastrointestinal absorption deficits; (2).have severe pulmonary hypertension (peak tricuspid regurgitation flow rate > 3.4 m/s on cardiac ultrasound), or extrapulmonary pathological abnormalities (e.g., chest wall deformities, large volume pleural effusions); (3).myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty(PTCA), coronary artery bypass grafting, heart failure (New York Heart Association Cardiac Function Class >II), transient ischemic attack (TIA), cerebral vascular infarction, cerebral hemorrhage, or subarachnoid hemorrhage in the 3 months prior to screening; (4).comorbidities such as the unstable cardiovascular disease (e.g., blood pressure failed to be controlled after 3 months of standard treatment for hypertension, systolic blood pressure(SBP) >=160 mmHg and/or diastolic blood pressure(DBP) >=100 mmHg); (5).participant with history of malignancy (except those who have achieved complete remission for five years prior to the screening of this study, who do not require any other treatment currently or during the following study period); (6).diagnosed cardiovascular, hepatic, renal, gastrointestinal, immune, endocrine, metabolic, psychiatric and/or psychological, neurological, and hematological and lymphatic systems prior to screening period, and not appropriate for the trial as judged by the clinical investigator; 11.The participant will be excluded with any abnormality of laboratory test of imaging as in followings: (1).blood cell count: hemoglobulin1.5 times of upper limits of normal (ULN); (3).renal function: creatinine clearance = 1.5 times of the upper limit of normal [measured values, or value
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Serious Adverse event;adverse drug reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreasing Dose of daily oral hormones (mg/ day);Percentage reduction (%) in daily oral hormones;Time to reach the target maintenance dose;Number of patients who reached the target maintenance dose and were maintained through 24 weeks; | — |
Countries
China
Contacts
Public ContactDai Huaping
China-Japan Friendship Hospital
Outcome results
None listed