Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis

NCT07192939 | Recruiting Phase 2

• 1 other identifier: HRS-9813-201
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。

Conditions

IPF and PPF

Outcome Measures

Primary Outcomes (1)

• FVC as a percentage of the predicted value

  The baseline period lasted until 26weeks after administration

Secondary Outcomes (10)

• The rate of change in ppFVC

  The baseline period lasted until 26 weeks after administration

• Absolute change in FVC.

  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).

  The baseline period lasted until 26 weeks after administration

• Proportion of subjects with an absolute decline in ppFVC (%) of ≥10% from baseline.

  The baseline period lasted until 26 weeks after administration

• Proportion of subjects with acute exacerbation of pulmonary fibrosis.

  The baseline period lasted until 26 weeks after administration

Study Arms (3)

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

Interventions

HRS-9813 capsules DRUG

HRS-9813 capsule; High dose

Treatment group A: HRS-9813 capsules

HRS-9813 capsule mimetic DRUG

HRS-9813 capsule mimetic

Treatment group C: HRS-9813 capsule mimetic.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Central Study Contacts

Jinrui Wang

CONTACT

+0518-81220121; jinrui.wang.jw207@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 25, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-09

Locations

CN (1)