IPFPhase 3NCT07519070
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis
A Phase 3 study testing HSK44459 in people with IPF, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- IPF
- What is being tested?
- HSK44459
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 30 Dec 2028
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years, regardless of gender;
- Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);
- Patients must meet one of the following criteria:
- No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;
- On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. [Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events];
- Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;
- Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and <90% at screening [*hemoglobin (Hb)-adjusted];
- Willing to participate and voluntarily sign the informed consent form.
Who cannot join
- Clinically significant airway obstruction during screening [pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7];
- Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);
- Acute IPF exacerbation within 3 months before screening and/or during screening;
- Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone >15 mg/day (or equivalent);
- History of vasculitis;
- Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviors);
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- Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before/during screening (active suicidal thoughts with method/intent but no plan, or with method/intent/plan);
- Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before/during screening;
- Major surgery within 3 months before screening or planned during the study (investigator-assessed; lung transplant listing excluded);
- Malignancy within 5 years before screening (except treated basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ);
- Blood pressure ≥160/100 mmHg at screening;
- Unstable/worsening cardiovascular/cerebrovascular disease within 6 months before screening (e.g., unstable angina, myocardial infarction, heart failure, thromboembolic events including stroke/TIA);
- Aspartate transaminase (AST) or alanine transaminase (ALT) >2.5×ULN or total bilirubin >1.5×ULN at screening;
- Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m² at screening;
- Gastrointestinal surgery/disease affecting pharmacokinetics (PK) (except appendectomy/hernia repair);
- Active hepatitis B [HBsAg-positive with HBV-DNA above ULN], hepatitis C antibody-positive, syphilis (anti-TP-positive with TRUST above ULN), or HIV infection (anti-HIV-positive) at screening;
- Current treated liver disease with Child-Pugh A/B/C impairment at screening;
- Substance abuse, drug use, or excessive alcohol intake (>2 units/day; 1 unit=360 mL beer [5%], 45 mL spirits [40%], or 150 mL wine) within 3 months before screening;
- Tobacco/nicotine product use within 3 months before screening or unwillingness to abstain during the study;
- Previous HSK44459 use or PDE1/3/4/10/non-selective PDE inhibitor treatment (excluding HSK44459, e.g., apremilast, roflumilast, ibudilast) within 8 weeks before screening;
- Use of strong CYP3A4 inhibitors/inducers within 14 days or 5 half-lives (whichever longer) before first dose, or anticipated need during the study;
- History of severe drug allergy or hypersensitivity to investigational product/excipients;
- Participation in other clinical trials (receiving investigational drug/placebo) within 1 month before screening;
- Pregnancy/lactation; participants of childbearing potential unwilling to use contraception during and for 3 months post-study (including male participants);
- Any other investigator-determined factors making participation unsuitable.
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
This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).
- Conditions
- IPF
- 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 Without IPF background therapy
HSK44459Drug
HSK44459 With Nintedanib
HSK44459Drug
HSK44459 With Pirfenidone
PlaceboDrug
Placebo Without IPF background therapy
PlaceboDrug
Placebo With Nintedanib
PlaceboDrug
Placebo With Pirfenidone
| Study group | Role | What they receive |
|---|---|---|
| HSK44459 | Experimental | Not described Receives: Drug: HSK44459 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FVC from baseline at Week 52
Measured: Week 52
Secondary outcomes (17)
Time to first acute IPF exacerbation during the trial
Measured: Week 52
Time to first respiratory-related hospitalization during the trial
Measured: Week 52
Time to >5% relative/absolute decline in FVC% predicted from baseline during the trial
Measured: Week 52
Time to >10% relative/absolute decline in FVC% predicted from baseline during the trial
Measured: Week 52
Time to >15% absolute decline in DLCO% predicted from baseline during the trial
Measured: Week 52
Time to first antifibrotic (rescue) therapy use during the trial (non-antifibrotic arm only)
Measured: Week 52
Time to death during the trial
Measured: Week 52
Change from baseline in Living with Pulmonary Fibrosis (L-PF) questionnaire total score, impact score, and symptom total score at Week 52
Measured: Week 52
Change from baseline in L-PF questionnaire symptom domain - dyspnea score at Week 52
Measured: Week 52
Change from baseline in L-PF questionnaire symptom domain - cough score at Week 52
Measured: Week 52
Change from baseline in L-PF questionnaire symptom domain - fatigue score at Week 52
Measured: Week 52
Change from baseline in EQ-5D score at Week 52
Measured: Week 52
Change from baseline in FVC at Week 26
Measured: Week 26
Absolute change from baseline in FVC% predicted at Weeks 26 and 52
Measured: Weeks 26 and 52
Absolute change from baseline in DLCO% predicted at Weeks 26 and 52
Measured: Weeks 26 and 52
Change from baseline in resting SpO2 (expressed as percentage) at Week 52
Measured: Week 52
Annualized rate of respiratory-related hospitalizations
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start5 Apr 2026 (estimated)
- Primary completion5 Apr 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies 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
- 420 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
- NCT07519070
- Sponsor's protocol ID
- HSK44459-301
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07519070
- Acronym / sponsor ID
- HSK44459-301
- Conditions
- IPF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 5 Apr 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Apr 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 aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).
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 |
|---|---|---|
| HSK44459 | Experimental | Drug: HSK44459 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥40 years, regardless of gender;
- Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);
- Patients must meet one of the following criteria:
- Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;
- Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and <90% at screening [*hemoglobin (Hb)-adjusted];
Key exclusion criteria (25 listed)
- Clinically significant airway obstruction during screening [pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7];
- Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);
- Acute IPF exacerbation within 3 months before screening and/or during screening;
- Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone >15 mg/day (or equivalent);
- 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 Without IPF background therapy | Drug | HSK44459 |
| HSK44459HSK44459 With Nintedanib | Drug | HSK44459 |
| HSK44459HSK44459 With Pirfenidone | Drug | HSK44459 |
| PlaceboPlacebo Without IPF background therapy | Drug | Placebo |
| PlaceboPlacebo With Nintedanib | Drug | Placebo |
| PlaceboPlacebo With Pirfenidone | Drug | Placebo |
Primary outcome
Change in FVC from baseline at Week 52
Time frame: Week 52
17 secondary outcomes
Time to first acute IPF exacerbation during the trial
Time frame: Week 52
Time to first respiratory-related hospitalization during the trial
Time frame: Week 52
Time to >5% relative/absolute decline in FVC% predicted from baseline during the trial
Time frame: Week 52
Time to >10% relative/absolute decline in FVC% predicted from baseline during the trial
Time frame: Week 52
Time to >15% absolute decline in DLCO% predicted from baseline during the trial
Time frame: Week 52
Time to first antifibrotic (rescue) therapy use during the trial (non-antifibrotic arm only)
Time frame: Week 52
Time to death during the trial
Time frame: Week 52
Change from baseline in Living with Pulmonary Fibrosis (L-PF) questionnaire total score, impact score, and symptom total score at Week 52
Time frame: Week 52
Change from baseline in L-PF questionnaire symptom domain - dyspnea score at Week 52
Time frame: Week 52
Change from baseline in L-PF questionnaire symptom domain - cough score at Week 52
Time frame: Week 52
Change from baseline in L-PF questionnaire symptom domain - fatigue score at Week 52
Time frame: Week 52
Change from baseline in EQ-5D score at Week 52
Time frame: Week 52
Change from baseline in FVC at Week 26
Time frame: Week 26
Absolute change from baseline in FVC% predicted at Weeks 26 and 52
Time frame: Weeks 26 and 52
Absolute change from baseline in DLCO% predicted at Weeks 26 and 52
Time frame: Weeks 26 and 52
Change from baseline in resting SpO2 (expressed as percentage) at Week 52
Time frame: Week 52
Annualized rate of respiratory-related hospitalizations
Time frame: Week 52
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 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for IPF
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RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
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 IPF, 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 8 inclusion and 25 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 9 Apr 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 Zuojun Xu, PhD (+86-010-69156114, xuzj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FVC from baseline at Week 52 (time frame: 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 9 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.