Idiopathic Pulmonary Fibrosis (IPF)Phase 2IPFNCT07728721
Evaluating the Efficacy and Safety of of HSK50042 in People With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing HSK50042 dose 1, HSK50042 dose 2 and HSK50042 dose 3 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Haisco Pharmaceutical Group Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- HSK50042 dose 1, HSK50042 dose 2 and HSK50042 dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2026to 25 Jul 2028
- Phase
- Phase 2
- 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
- 1. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:
- 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.
- 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% and<90% of predicted normal at screening period.
- 4. Patients have to be either:
- 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.
- on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the 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 IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
- History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
- 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).
- Uncontrolled hypertension at screening or prior to randomization/investigational product administration (defined as refractory hypertension as assessed by the investigator, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); or hypotension (seated systolic blood pressure <100 mmHg or diastolic blood pressure <60 mmHg).
- Administration of systemic corticosteroids equivalent to >15 mg prednisone per day within 4 weeks prior to screening and/or during the screening period.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Parallel Group Phase II Clinical Study Evaluating the Efficacy and Safety of HSK50042 in Subjects With Idiopathic Pulmonary Fibrosis
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- HSK50042 dose 1, HSK50042 dose 2, HSK50042 dose 3, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK50042 dose 1Drug
HSK50042 taken orally once daily in the morning for 26 weeks.
HSK50042 dose 2Drug
HSK50042 taken orally once daily in the morning for 26 weeks.
HSK50042 dose 3Drug
HSK50042 taken orally once daily in the morning for 26 weeks.
PlaceboDrug
Placebo matching HSK50042 taken orally once daily in the morning for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HSK50042-dose 1 | Experimental | HSK50042 taken orally once daily in the morning for 26 weeks. Receives: Drug: HSK50042 dose 1 |
| HSK50042-dose 2 | Experimental | HSK50042 taken orally once daily in the morning for 26 weeks. Receives: Drug: HSK50042 dose 2 |
| HSK50042-dose 3 | Experimental | HSK50042 taken orally once daily in the morning for 26 weeks. Receives: Drug: HSK50042 dose 3 |
| Placebo | Experimental | Placebo matching HSK50042 taken orally once daily in the morning for 26 weeks. Receives: Drug: Placebo |
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 12
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Measured: week 12
Secondary outcomes (2)
The change from baseline in forced vital capacity (FVC) at week 26
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Measured: week 26
The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12/26
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Measured: week12/26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Aug 2026 (estimated)
- Primary completion10 Apr 2028 (estimated)
- Study completion25 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 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
- NCT07728721
- Sponsor's protocol ID
- HSK50042-201
- Acronym
- IPF
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 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 27 Jul 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 II Clinical Study Evaluating the Efficacy and Safety of HSK50042 in Subjects With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07728721
- Acronym / sponsor ID
- IPF / HSK50042-201
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 10 Apr 2028 (estimated)
- Study completion
- 25 Jul 2028 (estimated)
- First posted
- 27 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK50042-dose 1 | Experimental | Drug: HSK50042 dose 1HSK50042 taken orally once daily in the morning for 26 weeks. |
| HSK50042-dose 2 | Experimental | Drug: HSK50042 dose 2HSK50042 taken orally once daily in the morning for 26 weeks. |
| HSK50042-dose 3 | Experimental | Drug: HSK50042 dose 3HSK50042 taken orally once daily in the morning for 26 weeks. |
| Placebo | Experimental | Drug: PlaceboPlacebo matching HSK50042 taken orally once daily in the morning for 26 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:
- 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.
- 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% and<90% of predicted normal at screening period.
- 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.
Key exclusion criteria (7 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 IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
- History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
- 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).
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 |
|---|---|---|
| HSK50042 dose 1HSK50042 taken orally once daily in the morning for 26 weeks. | Drug | HSK50042-dose 1 |
| HSK50042 dose 2HSK50042 taken orally once daily in the morning for 26 weeks. | Drug | HSK50042-dose 2 |
| HSK50042 dose 3HSK50042 taken orally once daily in the morning for 26 weeks. | Drug | HSK50042-dose 3 |
| PlaceboPlacebo matching HSK50042 taken orally once daily in the morning for 26 weeks. | Drug | Placebo |
Primary outcome
The change from baseline in forced vital capacity (FVC) at week 12
Time frame: week 12
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
2 secondary outcomes
The change from baseline in forced vital capacity (FVC) at week 26
Time frame: week 26
The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12/26
Time frame: week12/26
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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK50042 dose 1, HSK50042 dose 2 and HSK50042 dose 3 in people with Idiopathic Pulmonary Fibrosis (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 7 inclusion and 7 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 27 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 12 (time frame: week 12). 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 27 Jul 2026.