Actively Recruiting
Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-12-24
270
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent to participate in the trial
- Aged 21 years or older for PPF, or 45 years or older for IPF
- Diagnosed with IPF within 7 years before screening or evidence of progressive ILD within 12 months before screening
- Diagnosis supported by HRCT and lung biopsy or transbronchial lung cryobiopsy when available
- Central HRCT reading shows more than 10% lung parenchymal fibrosis for PPF at screening
- Discontinued nintedanib or pirfenidone at least 8 weeks before screening or stabilized on treatment for at least 8 weeks
- Forced vital capacity (FVC) at least 40% of predicted normal value
- DLCO SB (Hb corrected) at least 25% of predicted normal value
- Female participants of childbearing potential must have a negative pregnancy test before first dose, must not be breastfeeding, and agree to use effective contraception during and 14 days after treatment
- Male participants whose partner is of childbearing potential agree to use effective contraception during and 14 days after treatment
You will not qualify if you...
- For IPF cohort: other known causes of interstitial lung disease; sarcoidosis or systemic autoimmune disease
- For PPF cohort: IPF diagnosis with usual interstitial pneumonia features supported by imaging or biopsy
- Emphysema involving 50% or more of lungs or greater than fibrosis extent on latest HRCT
- Clinically significant nonsubstantial lung disease affecting study assessments
- Pulmonary hypertension requiring multiple medications
- Active tuberculosis within 12 months or recent lower respiratory infection requiring antibiotics
- Acute exacerbations of IPF or ILD within 12 weeks before or during screening
- Unstable or worsening cardiac disease within 6 months before screening
- Uncontrolled arrhythmias or significant left ventricular dysfunction
- Recent cerebrovascular event requiring hospitalization within 6 months
- History of lung volume reduction surgery or transplant, or planned surgery/transplant during study
- History or suspicion of malignancy within 5 years or uncertain malignancy status after evaluation
- Positive hepatitis B surface antigen or hepatitis C antibody; positive HIV antibody
- Smoking within 3 months before screening or unwillingness to quit during study
- Regular alcohol use in 6 months before screening or unwillingness to reduce intake during study
- History of substance abuse within 6 months before screening
- Pregnant or breastfeeding
- Use of prednisone over 15 mg/day or equivalent glucocorticoids within 4 weeks before screening or during study
- Use of IL-6 inhibitors, disease-modifying antirheumatic drugs, or immunosuppressive drugs within 3 months before screening or planned use during study
- Rituximab use within 6 months before screening or planned use during study
- Use of potent CYP3A4 inhibitors or inducers within 4 weeks before randomization or planned use during study
- Participation in other drug or device trials within 1 month before screening or with residual effects
- Major surgery under general anesthesia within 3 months before screening or planned during study
- Uncontrolled hypertension before screening or randomization
- History of orthostatic intolerance, hypotension, tachycardia, or syncope
- Abnormal liver enzymes, blood counts, or other lab abnormalities exceeding limits
- ECG showing heart rate below 55 bpm, QT interval ≥500 msec, or QTcF interval ≥450 msec before randomization
- Allergy to drugs in the same class or components of HRS-9813
- Other investigator-determined reasons preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
Jinrui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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