Status:
NOT_YET_RECRUITING
Clinical Study on the Efficacy and Safety of SHR-4597 Inhalant in Adult Patients With Asthma
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study
Eligibility Criteria
Inclusion
- Age ≥18 years old and ≤75 years old, gender is not limited;
- Body mass index (BMI) ≥18 and ≤30 kg/m2 during screening period;
- Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;
- Did not receive inhaled corticosteroids (ICS) and/or combined with other asthma control medications within 2 weeks prior to randomization;
- FEV1 during the screening period and before bronchodilator inhalation at baseline accounted for ≥40% and \< 80% of the estimated value;
- Screening and baseline visit, Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5;
- FeNO values at screening period and baseline ≥25 ppb;
- Patients with asthma who were treated for the first time or who had previously taken irregular medication were selected; Among them, the definition of irregular past use was: patients did not regularly use asthma control drugs within the first 3 months of enrollment, and the average weekly use compliance was \< 50%.
- A fertile female subject or a male subject whose partner is a fertile female must agree not to have a family plan and to voluntarily use highly effective contraception (including the partner) from the time of signing the informed consent until 1 month after the last study drug administration, and refrain from sperm/egg donation;
- Voluntarily sign informed consent to participate in this study.
- The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
- The researchers determined that there were other circumstances that were not suitable for participation in this study.
Exclusion
- Combined diseases or conditions
- Clinically significant pulmonary diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD);
- Malignant tumors diagnosed within 5 years prior to randomization (except those with a low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and/or diastolic blood pressure ≥110mmHg during the screening period) or uncontrolled severe cardiovascular and cerebrovascular diseases; ④ Known immunodeficiency;
- A history of infection requiring clinical intervention within 4 weeks prior to randomization, including but not limited to respiratory infection;
- ⑥ Known presence of parasitic infection within 6 months prior to randomization;
- ⑦ Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization;
- ⑧ A history of life-threatening acute asthma attacks (including admission to the intensive care unit and/or the need for invasive ventilator support \[intubation/tracheotomy\]);
- ⑨ History of acute asthma attack in the 4 weeks prior to randomization.
- Combination of medication or treatment
- Receiving non-selective beta-blockers (e.g., propranolol) within 1 week prior to screening;
- Live attenuated vaccine or recombinant vaccine with viral vector were received within 4 weeks before randomization;
- Receiving allergen immunotherapy 8 weeks before randomization;
- Within 12 weeks before randomization or within 5 half-lives of the drug (refer to the drug instructions, whichever is older; For those with unknown half-lives, the first 12 weeks of randomization will be the use of systemic immunosuppressants (except for systemic glucocorticoids for asthma treatment, and systemic glucocorticoids for other conditions \<3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, Including but not limited to methotrexate, cyclosporine, interferon-alpha, anti-IL-5 monoclonal antibody,anti-TSLP monoclonal antibody, anti-IGE monoclonal antibody, mesulast, etc.
- Receiving a single dose of long-acting β2 agonist within 4 weeks prior to screening; ⑥4 weeks before randomization, inhaled corticosteroids (\>500 micrograms of beclomethasone dipropionate per day \[BDP\] or equivalent dose);
- ⑦4 weeks before randomization, systemic glucocorticoid therapy;
- Received bronchial thermoplasty or bronchial cryoablation within 1 year before randomization; ⑨There is a surgical plan during the study, or other treatment that the investigator believes may affect the evaluation of the subject;
- Laboratory examination
- ①Significant abnormalities during screening or baseline laboratory tests:
- White blood cell (WBC) \< 3.0×109/L;
- Blood eosinophils \>1500cells/μL (1.5×109/L)
- Hemoglobin (Hb) ≤90 g/L;
- Alanine aminotransferase (ALT) \> 3×ULN (upper limit of normal);
- Aspartate aminotransferase (AST) \> 3×ULN;
- Total bilirubin (TBIL) \> 1.5×ULN;
- Prothrombin time (PT) \> ULN+3s;
- Creatinine (Cr) \> 1.5×ULN;
- Co-active hepatitis B (peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥1×103 IU\[or copy\] / mL), or hepatitis C antibody positive, or human immunodeficiency virus (HIV) positive, or treponema pallidum antibody positive.
- Prolonged ECG QTc interval (\>450ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
- General situation
- Smoking or smoking cessation less than 6 months during the screening period, or previous smoking ≥10 pack years (pack years = number of years of smoking × number of packs per day); ②A history of drug use, alcohol abuse (average weekly consumption of ≥14 units of alcohol: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine) or drug abuse in the year prior to screening;
- Have participated in other clinical studies and used investigational drugs containing active ingredients within 30 days prior to screening, or have been within 5 half-lives of investigational drugs at the time of screening (whichever is older);
- Subjects who are pregnant (screening or baseline blood pregnancy test positive) or who plan to become pregnant while breastfeeding or during the study; ⑥Other reasons deemed unsuitable for study participation by the researcher.
- Excessive alcohol consumption and drug abuse were prohibited throughout the study period (the definition of excessive alcohol consumption is the same as exclusion criterion IV.2).
- Smoking (including e-cigarettes) was prohibited throughout the study period.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06940700
Start Date
April 1 2025
End Date
December 1 2025
Last Update
April 23 2025
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China