Allergic bronchopulmonary aspergillosis
Conditions
Interventions
Treatment group:SHR1703 injection
Placebo group:placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old and <=75 years old, gender is not limited; 2. ABPA diagnostic criteria in line with current guidelines; 3. At least one history of acute exacerbation of ABPA in the year before randomization; 4. Received stable dose of ABPA within 4 weeks before randomization; 5. The fertile female subject agrees to have no birth plan and take it voluntarily for 15 months from the signing of the informed consent to the last dose; 6. Voluntarily sign informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Other major lung diseases (such as lung cancer, pulmonary fibrosis, etc.) associated with ABPA; 2. Associated with other eosinophilic elevation-related diseases, including but not limited to eosinophilic granulocytosis syndrome (HES), eosinophilic granulomatous polyvasculitis (EGPA) and eosinophilic esophagitis; 3. Malignant tumors diagnosed within 5 years prior to screening (except malignant tumors with low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); 4. Various chronic diseases with poorly controlled conditions (including but not limited to hypertension, myocardial infarction, unstable angina pectoris, heart failure, stroke and subarachnoid hemorrhage); 5. A history of infection requiring clinical intervention within 4 weeks prior to randomization; 6. Known presence of parasitic infection within 6 months prior to randomization; 7. Within 12 weeks before randomization or within 5 half-lives of the drug (refer to the drug instructions, whichever is older; Biological agents or Th2 cytokines inhibitors, including but not limited to anti-IL-4ra monoclonal antibody, anti-IL-5 monoclonal antibody, anti-IGE monoclonal antibody, etc., were used in patients with unknown half-life at the first 12 weeks of randomisation. 8. Laboratory tests during the screening period showed obvious abnormalities: 1) White blood cell (WBC) 3×ULN (upper limit of normal); 4) Aspartate aminotransferase (AST) >3×ULN; 5) Total bilirubin (TBIL) >1.5×ULN; 6) Serum creatinine (Cr) >1.5×ULN. 9. Screening period combined with clinically significant ECG abnormalities that may bring significant safety risks to subjects; 10. Participated in another clinical study and used the investigational drug containing the active ingredient within 30 days prior to randomization, or remained within 5 half-lives of the investigational drug at the time of randomization (if older); 11. Subjects who are pregnant (positive pregnancy test) or who plan to become pregnant while breastfeeding or during the study; 12. Allergy or intolerance to IL-5 monoclonal antibody or other biologic agents; 13. Other reasons deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with acute exacerbation of ABPA within 24 weeks of treatment;Decrease in oral glucocorticoids (OCS, prednisone/prednisone, or equivalent hormones) from baseline at 48 weeks of visit; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with acute exacerbations of ABPA within 48 weeks, 72 weeks of treatment;Number of acute exacerbations of ABPA within 24 weeks, 48 weeks, 72 weeks of treatment;Annualized rate of acute exacerbations of ABPA at 24 weeks, 48 weeks, 72 weeks of treatment;Time to first acute exacerbation of ABPA;Proportion of subjects with ABPA composite response at 24-week, 48-week, 72-week visits;Change from baseline in FEV1 before and after inhaled bronchodilator at each evaluation time point;Percentage of FEV1 before and after inhaled bronchodilator and change from baseline at each evaluation time point;Change from baseline in FVC before and after inhaled bronchodilators at each evaluation time point;Peak expiratory flow (PEF) before and after inhaled bronchodilator at each evaluation time point and its change from baseline;Change from baseline in FeNO at each evaluation time point;Change from baseline in blood EOS at each evaluation time point;Change from baseline in serum total IgE at each evaluation time point;Change from baseline in ACQ-5 score at each review time point;Change from baseline in AQLQ score at each review time point;Change from baseline in SGRQ score at each evaluation time point;The VAS score of ABPA-related symptoms (stridor, cough, chest tightness and dyspnea) at each evaluation time point was relatively basic Changes in the line;Cough-related scores (Leesster Cough Questionnaire, Cough Symptom Score Scale) and respiratory distress at each evaluation time point Change from baseline in difficulty-related scores (Borg scale, mMRC grade, and dyspnea-12 questionnaire).; | — |
Countries
China
Contacts
Public ContactWeimin Li/Gang Wang
West China Hospital of Sichuan University
Outcome results
None listed