This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment of idiopathic pulmonary fibrosis (IPF). The study will be conducted in China and divided into two stages, both of which are multicentre, randomised, double-blind, placebo-controlled studies. Stage 1 aims to evaluate the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients, and Stage 2 aims to further confirm the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients.
Diagnosed with IPF
Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);
Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of "indeterminate for UIP", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show "UIP" or "probable UIP", the clinical diagnosis of IPF can be confirmed;
Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;
Diagnosed with IPF
Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);
Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of "indeterminate for UIP", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show "UIP" or "probable UIP", the clinical diagnosis of IPF can be confirmed;
Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;
Parallel
TDI01
DrugTDI01 suspension
Primary Outcome Measure
Absolute change in forced vital capacity (FVC) (mL) from baseline at Week 24 and week 52.
Secondary efficacy endpoints:
Absolute change in FVC (mL) from baseline at Weeks 6 and 12.
Secondary Outcome Measure
Time (days) to the first occurrence of ppFVC% absolute decline \>10%, acute exacerbation of IPF (AE-IPF), hospitalisation due to respiratory causes, or death due to respiratory causes (whichever occurs first) during the trial period;
Secondary Outcome Measure
Absolute change from baseline in FVC percent predicted (ppFVC%), six minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ) score, and carbon monoxide diffusing capacity (DLco%) (Hb-corrected) at Week 24 and 52.
Secondary Outcome Measure
Time (days) to a 10% absolute decline in ppFVC%;
Exploratory endpoints:
Thoracic imaging progression on HRCT, such as new ground-glass opacity with traction bronchiectasis, new fine reticular pattern, increased extent or severity of coarse reticular pattern, new honeycombing, or worsening of existing honeycombing.
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Beijing Tide Pharmaceutical Co., Ltd
Lead sponsor
China-Japan Friendship Hospital
Collaborator
