Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK44459, Placebo.
- Who it may be relevant to
- Registry conditions: Progressive Pulmonary Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomised, Double-blind, Placebo-controlled Parallel Group Phase III Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Subjects With Progressive Pulmonary Fibrosis
Overview
This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Interventions
- Drug HSK44459
HSK44459 taken orally twice daily in the morning and in the evening for 52weeks. - Drug Placebo
Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks
Primary outcome measures
- The change from baseline in forced vital capacity (FVC) at week 52 [Time frame: day 1 and week 52]
Eligibility criteria
Inclusion criteria
- Adults aged ≥18 year.
- Diagnosis of PPF other than IPF prior to screening or during the screening period.
- Patients must meet either of the following conditions:
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 antiibrotic therapy.
2.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period.
4.Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 5.Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and <90% of predicted normal at screening period .
Exclusion criteria
- Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at screening.
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute ILD exacerbation within 3 months prior to screening and/or during the screening period.
- History of malignancy within 5 years prior to screening.
- History of vasculitis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07503587 · HSK44459-302