The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage
taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage
taking Placebo orally once daily, up to 24 weeks in main stage
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange from Baseline to Week 24 in FVC (mL) compared with placebo
change in FVC (mL), measured using Spirometer, from baseline to week 24
Time frame: 24 Weeks
Change from Baseline to Week 12 in FVC (mL) compared with placebo
change in FVC (mL), measured using Spirometer, from baseline to week 12
Time frame: 12 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%
The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at week 24
Time frame: 24 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%
The proportion of subjects whose %FVC decline from baseline by more than 5% in each treatment group at week 24
Time frame: 24 Weeks
Changes of DLco (Hb correction)
Time frame: 12 Weeks, 24 Weeks
Changes of 6MWT results
Time frame: 12 Weeks, 24 Weeks
Changes of St George' s Respiratory Questionnaire (SGRQ)
The higher the score, the more serious the impact on life
Time frame: 12 Weeks, 24 Weeks
Changes of The University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ)
Scores range from 0 to 120. The higher the score, the more severe the difficulty in breathing
Time frame: 12 Weeks, 24 Weeks
Changes of Leicester coughing questionnaire scores
Scores range from 3 to 21. The lower the score, the greater the impact of cough on quality of life
Time frame: 12 Weeks, 24 Weeks
Changes of HRCT
Time frame: 24 Weeks
Time to first acute ILD exacerbation or death
the time duration from randomization to first acute ILD exacerbation or death whichever occurs first
Time frame: 24 Weeks
Proportion of subjects with death caused by any reason(s)
Time frame: 24 Weeks
Proportion of subjects with death caused by the respiratory reason
Time frame: 24 Weeks
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