Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
Interventions
DRUGHEC585
HEC585 Tablets，once daily
DRUGPirfenidone
Pirfenidone，three times a day
DRUGPlacebo
Placebo，once daily
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo-controlled (double-blind design), active comparator-controlled (open-label design)，parallel-group
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Volunteer to participate in this clinical study and sign the ICF before the study begins; * Aged 40-80 (including 40 and 80) ; * Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures; * Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018); * FEV1/FVC ≥ 0.7; * FVC ≥ 45% predicted; * DLCO corrected for Haemoglobin (Hb) ≥ 30% predicted of normal; * In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit.
Exclusion criteria
* In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization; * Interstitial lung disease caused by other known causes; * Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening; * Expected to receive lung transplantation during the study; * Expected survival is less than 6 months; * History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma); * Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4); * History of unstable or worsening heart disease within 6 months before screening; * Cannot perform 6MWT or PFT; * Allergic to any component of HEC585 Tablets or pirfenidone tablets; * Participated in other clinical study and received the last dose within 3 months before screening; * Pregnant or breastfeeding; * History of smoking within 3 months before screening or are unwilling to quit smoking during the study; * Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study; * History of drug abuse within 6 months before the screening; * Family or personal history of QT prolongation syndrome; * Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study. * TBil \> 1.5 × ULN or AST or ALT \> 2 × ULN; * CLcr \< 50 mL/min; * Human immunodeficiency virus (HIV) antibody is positive; * Uncontrolled hepatitis B virus infection or hepatitis C virus infection; * QTcF \> 480 ms. * Subjects have received any of the following treatments within 28 days before randomization: 1. Any cytotoxic drug or immunosuppressant 2. Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at \> 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at \> 600 mg/d. 3. Moderate and strong inhibitor or strong inducer of CYP1A2. 4. Strong inducers or strong CYP3A4 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 24 in %FVC compared with placebo | 24 Weeks | change in %FVC, measured using Spirometer, from baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 24 in %FVC compared with Pirfenidone | 24 Weeks | change in %FVC, measured using Spirometer, from baseline to week 24 |
| Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone | 12 Weeks | change in %FVC, measured using Spirometer, from baseline to week 12 |
| Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10% | 24 Weeks | The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at W24 |
| Time to first acute IPF exacerbation | 24 Weeks | — |
| All-cause mortality | 24 Weeks | — |
| IPF related mortality | 24 Weeks | — |
| Changes of 6MWT results | 12 Weeks, 24 Weeks | — |
| Changes of SGRQ scores | 12 Weeks, 24 Weeks | — |
| Changes of DLco (Hb correction) | 12 Weeks, 24 Weeks | — |
| Changes of resting SpO2 | 12 Weeks, 24 Weeks | — |
Countries
China
Outcome results
None listed