Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Interventions
DRUGHSK44459 dose 1
HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
DRUGHSK44459 dose 2
HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
DRUGHSK44459 dose 3
HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
DRUGPlacebo
Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria: 1. IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy. 2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy. 2\. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% of predicted normal at screening period. 4\. Patients have to be either: 1. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy. 2. on stable therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period.
Exclusion criteria
1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at screening. 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined). 4. Lower respiratory tract infection requiring antibiotics within 2 weeks prior to screening and/or during the screening period. 5. Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed). 6. History of malignancy within 5 years prior to screening. 7. Any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in forced vital capacity (FVC) at week 12 | day 1 and week 12 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change from baseline in FVC at week 12 | day 1 and week 12 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness |
| The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12 | day 1 and week 12 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness |
Countries
China
Outcome results
None listed