Progressive Pulmonary FibrosisPhase 3PPFNCT07503587
Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis
A Phase 3 study testing HSK44459 in people with Progressive Pulmonary Fibrosis, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Pulmonary Fibrosis
- What is being tested?
- HSK44459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 1 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Progressive Pulmonary Fibrosis
- Being tested
- HSK44459, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK44459Drug
HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.
PlaceboDrug
Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| HSK44459 | Experimental | Not described Receives: Drug: HSK44459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in forced vital capacity (FVC) at week 52
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Measured: day 1 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start5 Apr 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503587
- Sponsor's protocol ID
- HSK44459-302
- Acronym
- PPF
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07503587
- Acronym / sponsor ID
- PPF / HSK44459-302
- Conditions
- Progressive Pulmonary Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| HSK44459 | Experimental | Drug: HSK44459 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK44459HSK44459 taken orally twice daily in the morning and in the evening for 52weeks. | Drug | HSK44459 |
| PlaceboPlacebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks | Drug | Placebo |
Primary outcome
The change from baseline in forced vital capacity (FVC) at week 52
Time frame: day 1 and week 52
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK44459 in people with Progressive Pulmonary Fibrosis, run by Haisco Pharmaceutical Group Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun luyin (028-67258779, sunluyin@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in forced vital capacity (FVC) at week 52 (time frame: day 1 and week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.