IPF and PPFPhase 2NCT07192939
Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis
A Phase 2 study testing HRS-9813 capsules and HRS-9813 capsule mimetic in people with IPF and PPF, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- IPF and PPF
- What is being tested?
- HRS-9813 capsules and HRS-9813 capsule mimetic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2025to Jun 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent was obtained to participate in the trial
- Patients were aged ≥21 years for PPF and ≥45 years for IPF.
- IPF diagnosed within 7 years before screening (including the screening period) or evidence of progressive ILD within 12 months before screening;
- HRCT and surgical lung biopsy or transbronchial lung cryobiopsy, when available, support the clinical diagnosis;
- The central HRCT reading results of PPF at screening showed that the whole lung parenchymal fibrosis was > 10%;
- Treatment with nintedanib or pirfenidone was discontinued at least 8 weeks before screening or was stabilized for at least 8 weeks;
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- FVC as a percentage of normal predicted value ≥40%;
- DLCO SB (Hb corrected) as a percentage of normal predicted value ≥25%;
- Female subjects of childbearing potential must have a negative pregnancy test before the first dose of medication. And must be non-lactating. Female subjects of childbearing potential or male subjects whose partner is a female of childbearing potential agree to be infertile, have a sperm/egg donation plan, and voluntarily use highly effective contraception (including their partner) from the time they sign ICF until 14 days after the last dose of medication, which is the end of safety follow-up.
Who cannot join
- IPF cohort: i. Interstitial lung disease (ILD) of other known cause; ii. Diagnosis of sarcoidosis or any systemic autoimmune disease；
- PPF cohort: IPF diagnosis and UIP features supported by HRCT central reading, surgical lung biopsy, or cryobiopsy pathology.
- The presence of emphysema of 50% or more on centrally read HRCT or the degree of emphysema greater than the degree of fibrosis on the basis of the most recent HRCT report.
- The presence of clinically significant nonsubstantial lung disease was considered by the investigator to be likely to affect the assessment of the study.
- Subjects were known to have pulmonary hypertension requiring treatment with multiple medications.
- Active tuberculosis infection within 12 months before and/or during screening, or lower respiratory tract infection requiring antibiotic treatment within 4 weeks before and/or during screening, or evidence of active infection on clinical and laboratory tests at the screening/baseline visit.
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- Acute exacerbations of IPF/ILD occurred within 12 weeks before and/or during screening.
- A history of unstable or worsening cardiac disease within 6 months before screening
- Uncontrolled atrial or ventricular arrhythmias or the known presence of significant left ventricular dysfunction.
- A cerebrovascular event leading to hospitalization had occurred within 6 months before screening
- Had a history of lung volume reduction surgery or transplant, were awaiting lung transplant, or were scheduled to undergo lung volume reduction surgery or transplant during the study period.
- Subjects with a history of malignancy within the previous 5 years, or a suspicion of malignancy on biopsy, and those for whom the possibility of malignancy could not be reasonably ruled out after additional clinical, laboratory, or other diagnostic evaluation were screened.
- The patients were positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) at the time of screening. A test for antibodies to the human immunodeficiency virus (HIV) was not negative at screening.
- A history of smoking (including e-cigarettes) within 3 months before screening or an unwillingness to quit smoking during the study.
- Regular alcohol consumption in the 6 months before screening or an unwillingness to reduce alcohol consumption to less than 21 units during the study.
- He had a history of substance abuse within 6 months before screening.
- Pregnant or breastfeeding.
- Treatment with prednisone at a dose of more than 15 mg per day or another systemic glucocorticoid at the equivalent dose was received within 4 weeks before screening and during the study.
- Use of an IL-6 inhibitor within 3 months before screening and planned use during the study.
- Disease-modifying antirheumatic drugs or a change in dose were initiated within 3 months before screening.
- Initiation of mycophenolate mofetil, mycophenolic acid, azathioprine, tacrolimus, methotrexate, leflunomide, or a change in the dose of the above drugs within 3 months before screening; Immunosuppressive drugs could not be started during the treatment phase.
- Rituximab was used 6 months before screening and was planned for the duration of the study.
- Participants who had used a potent inhibitor or inducer of cytochrome P450(CYP)3A4 within 4 weeks before randomization or who had to be treated with or planned to be treated with a drug ban during the study.
- Persons who had participated in a clinical trial of any drug or device within 1 month before screening and who had expected legacy effects of the trial treatment (at the discretion of the investigator) or who were within the follow-up period of a clinical study or the five half-lives of the trial drug before screening.
- Major surgery (surgery under general anesthesia) that was performed within 3 months before screening or that was planned during the study that, as assessed by the investigator, would affect the determination of the end points.
- Uncontrolled hypertension was present before screening or randomization.
- Patients with orthostatic intolerance, orthostatic hypotension, or orthostatic tachycardia, as well as patients with a previous history of these conditions, at screening or before randomization.
- A history of persistent or active syncope after urination/defecation, a previous known history of syncope, or a concomitant medical condition that increases the risk of syncope.
- Bilirubin, transaminase, blood routine and other abnormalities exceed the requirements during screening.
- An electrocardiogram showed a heart rate of less than 55 beats per minute before screening or randomization or a QT interval of at least 500 msec or a QTcF interval of at least 450 msec before randomization.
- Allergy to drugs in the same class or to any component of HRS-9813.
- Other reasons for not participating in the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
Zuojun Xu
About this study
To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。
- Conditions
- IPF and PPF
- Being tested
- HRS-9813 capsules, HRS-9813 capsule mimetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9813 capsulesDrug
HRS-9813 capsule; High dose
HRS-9813 capsulesDrug
HRS-9813 capsule; Low dose
HRS-9813 capsule mimeticDrug
HRS-9813 capsule mimetic
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-9813 capsules | Experimental | Not described Receives: Drug: HRS-9813 capsules |
| Treatment group B: HRS-9813 capsules | Experimental | Not described Receives: Drug: HRS-9813 capsules |
| Treatment group C: HRS-9813 capsule mimetic. | Placebo comparator | Not described Receives: Drug: HRS-9813 capsule mimetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC as a percentage of the predicted value
Measured: The baseline period lasted until 26weeks after administration
Secondary outcomes (10)
The rate of change in ppFVC
Measured: The baseline period lasted until 26 weeks after administration
Absolute change in FVC.
Measured: The baseline period lasted until 26 weeks after administration
Changes in lung carbon monoxide diffusion capacity (DLCO SB) (hemoglobin corrected) and its percentage of the predicted value (ppDLCO SB) (hemoglobin corrected).
Measured: The baseline period lasted until 26 weeks after administration
Proportion of subjects with an absolute decline in ppFVC (%) of ≥10% from baseline.
Measured: The baseline period lasted until 26 weeks after administration
Proportion of subjects with acute exacerbation of pulmonary fibrosis.
Measured: The baseline period lasted until 26 weeks after administration
Proportion of subjects with respiratory-related hospitalizations.
Measured: The baseline period lasted until 26 weeks after administration
Proportion of subjects with pulmonary fibrosis-related hospitalizations.
Measured: The baseline period lasted until 26 weeks after administration
All-cause mortality.
Measured: The baseline period lasted until 26 weeks after administration
Proportion of subjects with pulmonary fibrosis disease progression.
Measured: The baseline period lasted until 26 weeks after administration
The changes of the scores of each sub-item and the impact part of the Pulmonary fibrosis questionnaire (L-PF) were observed.
Measured: The baseline period lasted until 26 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start29 Oct 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPF and PPFStudies of the same condition, open and under way.
- 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192939
- Sponsor's protocol ID
- HRS-9813-201
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07192939
- Acronym / sponsor ID
- HRS-9813-201
- Conditions
- IPF and PPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Sep 2025 (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.
To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-9813 capsules | Experimental | Drug: HRS-9813 capsules |
| Treatment group B: HRS-9813 capsules | Experimental | Drug: HRS-9813 capsules |
| Treatment group C: HRS-9813 capsule mimetic. | Placebo comparator | Drug: HRS-9813 capsule mimetic |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent was obtained to participate in the trial
- Patients were aged ≥21 years for PPF and ≥45 years for IPF.
- IPF diagnosed within 7 years before screening (including the screening period) or evidence of progressive ILD within 12 months before screening;
- HRCT and surgical lung biopsy or transbronchial lung cryobiopsy, when available, support the clinical diagnosis;
- The central HRCT reading results of PPF at screening showed that the whole lung parenchymal fibrosis was > 10%;
Key exclusion criteria (32 listed)
- IPF cohort: i. Interstitial lung disease (ILD) of other known cause; ii. Diagnosis of sarcoidosis or any systemic autoimmune disease；
- PPF cohort: IPF diagnosis and UIP features supported by HRCT central reading, surgical lung biopsy, or cryobiopsy pathology.
- The presence of emphysema of 50% or more on centrally read HRCT or the degree of emphysema greater than the degree of fibrosis on the basis of the most recent HRCT report.
- The presence of clinically significant nonsubstantial lung disease was considered by the investigator to be likely to affect the assessment of the study.
- Subjects were known to have pulmonary hypertension requiring treatment with multiple medications.
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 |
|---|---|---|
| HRS-9813 capsulesHRS-9813 capsule; High dose | Drug | Treatment group A: HRS-9813 capsules |
| HRS-9813 capsulesHRS-9813 capsule; Low dose | Drug | Treatment group B: HRS-9813 capsules |
| HRS-9813 capsule mimeticHRS-9813 capsule mimetic | Drug | Treatment group C: HRS-9813 capsule mimetic. |
Primary outcome
FVC as a percentage of the predicted value
Time frame: The baseline period lasted until 26weeks after administration
10 secondary outcomes
The rate of change in ppFVC
Time frame: The baseline period lasted until 26 weeks after administration
Absolute change in FVC.
Time frame: The baseline period lasted until 26 weeks after administration
Changes in lung carbon monoxide diffusion capacity (DLCO SB) (hemoglobin corrected) and its percentage of the predicted value (ppDLCO SB) (hemoglobin corrected).
Time frame: The baseline period lasted until 26 weeks after administration
Proportion of subjects with an absolute decline in ppFVC (%) of ≥10% from baseline.
Time frame: The baseline period lasted until 26 weeks after administration
Proportion of subjects with acute exacerbation of pulmonary fibrosis.
Time frame: The baseline period lasted until 26 weeks after administration
Proportion of subjects with respiratory-related hospitalizations.
Time frame: The baseline period lasted until 26 weeks after administration
Proportion of subjects with pulmonary fibrosis-related hospitalizations.
Time frame: The baseline period lasted until 26 weeks after administration
All-cause mortality.
Time frame: The baseline period lasted until 26 weeks after administration
Proportion of subjects with pulmonary fibrosis disease progression.
Time frame: The baseline period lasted until 26 weeks after administration
The changes of the scores of each sub-item and the impact part of the Pulmonary fibrosis questionnaire (L-PF) were observed.
Time frame: The baseline period lasted until 26 weeks after administration
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 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for IPF and PPF
Active, not recruitingPhase 2
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A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
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SUPPORT-T in Patients With Progressive Pulmonary Fibrosis and Their Caregivers
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Not yet recruitingPhase 3
A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-9813 capsules and HRS-9813 capsule mimetic in people with IPF and PPF, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
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 9 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Contact Jinrui Wang (+0518-81220121, jinrui.wang.jw207@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC as a percentage of the predicted value (time frame: The baseline period lasted until 26weeks after administration). 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 24 Dec 2025.