Clinical Trials List
Protocol NumberD7700C00003
NCT Number(ClinicalTrials.gov Identfier)NCT07088926
Active
2025-10-01 - 2028-12-31
Recruiting7
ICD-10J47.9
Bronchiectasis, uncomplicated
ICD-9494.0
Bronchiectasis without acute exacerbation
A phase 2b, randomized, double-blind, placebo-controlled, parallel, multiple-dose trial was conducted to evaluate the efficacy, safety, and pharmacokinetics of AZD0292 in patients aged 12 years and older with bronchiectasis and chronic Pseudomonas aeruginosa grafts.
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/07
Investigators and Locations
Co-Principal Investigator
- Han-Lin Hsu Division of Thoracic Medicine
- Shian-Jiun Lin Division of Thoracic Medicine
- Chih-Hsin Lee Division of Thoracic Medicine
- Yu-Tien Tzeng Division of Thoracic Medicine
- Kuan-Jen Bai Division of Thoracic Medicine
- 江振源 Division of Thoracic Medicine
- 石智元 Division of Thoracic Medicine
- 楊善堯 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 覃俊士 Division of Thoracic Medicine
- Ming -Cheng Chan Division of Thoracic Medicine
- 王振宇 Division of Thoracic Medicine
- 王俊隆 Division of Thoracic Medicine
- 趙文震 Division of Thoracic Medicine
- 歐偉凡 Division of Thoracic Medicine
- 廖培雅 Division of Thoracic Medicine
- 莊子逸 Division of Thoracic Medicine
- 沈佩誼 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- jong rung Tsai Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- Wei-An Chang Division of Thoracic Medicine
- 鄭孟軒 Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- 陳家閔 Division of Thoracic Medicine
- 鄭至宏 Division of Thoracic Medicine
- Hung-Ling Huang Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
- 李岱晃 Division of Thoracic Medicine
- 張旭良 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Yen Tu Division of Thoracic Medicine
- 廖偉志 Division of Thoracic Medicine
- Wen-Chien Cheng Division of Thoracic Medicine
- 黃維俊 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃俊凱 Division of Thoracic Medicine
- CHUN-TA HUANG Division of Thoracic Medicine
- 鐘桂彬 Division of Thoracic Medicine
- JANN-YUAN WANG Division of Thoracic Medicine
- 錢穎群 Division of Thoracic Medicine
- 阮聖元 Division of Thoracic Medicine
- 廖庭淯 Division of Thoracic Medicine
- 黃昱璁 Division of Thoracic Medicine
- 李孟叡 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Chi-Li Chung Division of Thoracic Medicine
- Kai-Ling Lee Division of Thoracic Medicine
- Shang-Fu Hsu Division of Thoracic Medicine
- Shu-Leung Lai Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Horng-Chyuan Lin
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
In NCFBE and chronic PsA transfer subjects, the effect of AZD0292 IV every 4 weeks (Q4W) compared with placebo on the incidence of moderate to severe acute lung exacerbations was evaluated.
Objectives
This phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel, multiple-dose trial aimed to evaluate the efficacy, safety, and pharmacokinetics of intravenous AZD0292 in subjects with bronchiectasis and chronic Pseudomonas aeruginosa grafts who were receiving standard care.
Test Drug
AZD0292
Active Ingredient
AZD0292
Dosage Form
Injectable frozen powder
Dosage
380 mg/3.8 mL
Endpoints
In NCFBE and chronic PsA transfer subjects, the effect of AZD0292 IV every 4 weeks (Q4W) compared with placebo on the incidence of moderate to severe acute lung exacerbations was evaluated.
Inclution Criteria
Only participants meeting all of the following criteria are eligible to participate in this trial:
Age
1. Participants must be ≥ 12 years old at the time of signing the participant consent form. Only adults ≥ 18 years of age are eligible for inclusion in Taiwan.
Weight
2. Weight ≥ 35 kg
Participant Type and Disease Characteristics
3. Diagnosed with bronchiectasis by a physician and confirmed by computed tomography (CT) scan with abnormal bronchiectasis in ≥ 1 lung lobe.
Note: CT scans taken within the past 5 years are acceptable. If no previous scans are available, a CT scan should be performed during screening to confirm eligibility.
4. Medical history of ≥ 2 moderate or ≥ 1 severe acute exacerbation requiring antibiotic treatment within the past 12 months.
a) Moderate acute exacerbations require oral antibiotic treatment, while severe acute exacerbations require intravenous (IV) antibiotic administration and/or hospitalization.
b) Examples of documentation include, but are not limited to: hospital records, medical records, prescription records, and certified accurate copies of written records (e.g., X-rays, pharmacy records).
5. Subjects who are clinically stable and have not experienced acute exacerbations of bronchiectasis in the 4 weeks prior to randomization.
6. Subjects whose predicted forced expiratory volume in 1 second (FEV1) before or after bronchodilator use at the time of screening are ≥ 25%.
7. At least one respiratory specimen (polymerase chain reaction (PCR) or culture) positive for Pseudomonas aeruginosa (PsA) within the 24 months prior to screening*
8. Sputum culture positive for PsA within at least 5 weeks of randomization*†
*Subjects without a PsA-positive respiratory specimen in the past 24 months may submit two sputum specimens (at least 3 weeks apart) during the 5-week screening period. If both sputum specimens are PsA positive, they are considered to meet inclusion criteria 7 and 8 and can therefore be included.
†If the specimen collected during the screening follow-up visit is PsA negative, sputum specimens may be repeated during the screening period.
Informed Consent
9. Able to provide a signed subject consent form/agreement that includes compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this trial protocol.
Age
1. Participants must be ≥ 12 years old at the time of signing the participant consent form. Only adults ≥ 18 years of age are eligible for inclusion in Taiwan.
Weight
2. Weight ≥ 35 kg
Participant Type and Disease Characteristics
3. Diagnosed with bronchiectasis by a physician and confirmed by computed tomography (CT) scan with abnormal bronchiectasis in ≥ 1 lung lobe.
Note: CT scans taken within the past 5 years are acceptable. If no previous scans are available, a CT scan should be performed during screening to confirm eligibility.
4. Medical history of ≥ 2 moderate or ≥ 1 severe acute exacerbation requiring antibiotic treatment within the past 12 months.
a) Moderate acute exacerbations require oral antibiotic treatment, while severe acute exacerbations require intravenous (IV) antibiotic administration and/or hospitalization.
b) Examples of documentation include, but are not limited to: hospital records, medical records, prescription records, and certified accurate copies of written records (e.g., X-rays, pharmacy records).
5. Subjects who are clinically stable and have not experienced acute exacerbations of bronchiectasis in the 4 weeks prior to randomization.
6. Subjects whose predicted forced expiratory volume in 1 second (FEV1) before or after bronchodilator use at the time of screening are ≥ 25%.
7. At least one respiratory specimen (polymerase chain reaction (PCR) or culture) positive for Pseudomonas aeruginosa (PsA) within the 24 months prior to screening*
8. Sputum culture positive for PsA within at least 5 weeks of randomization*†
*Subjects without a PsA-positive respiratory specimen in the past 24 months may submit two sputum specimens (at least 3 weeks apart) during the 5-week screening period. If both sputum specimens are PsA positive, they are considered to meet inclusion criteria 7 and 8 and can therefore be included.
†If the specimen collected during the screening follow-up visit is PsA negative, sputum specimens may be repeated during the screening period.
Informed Consent
9. Able to provide a signed subject consent form/agreement that includes compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this trial protocol.
Exclusion Criteria
Subjects meeting any of the following criteria are ineligible to participate in the trial: Medical Conditions
1. Presence of a primary pulmonary diagnosis other than bronchiectasis (for subjects concurrently with asthma or chronic obstructive pulmonary disease (COPD), inclusion is permitted if the trial administrator deems bronchiectasis the primary diagnosis).
2. Evidence of active pulmonary tuberculosis or active nontuberculous mycobacterial infection and currently receiving or requiring treatment. Subjects currently receiving treatment for active pulmonary tuberculosis (TB) or nontuberculous mycobacterial infection may be considered for inclusion upon completion of an appropriate course of treatment.
3. Evidence of active allergic bronchopulmonary aspergillosis and currently receiving or requiring treatment.
4. Long-term need for supplemental oxygen. 5. Oxygen may be used for purposes such as walking and relieving shortness of breath after exercise.
6. Life-threatening hemoptysis or coughing up >200 cc of blood within 60 days prior to randomization.
7. Any condition deemed by the trial administrator to significantly increase the risk to the participant's participation, affect the participant's ability to participate, or affect the interpretation of trial data.
8. Current or past 5-year history of malignancy, excluding stable prostate cancer, appropriately treated non-invasive basal cell and squamous cell carcinoma of the skin, and cervical carcinoma in situ that has been treated and has shown apparent treatment success for more than one year prior to inclusion.
9. Acquired Immunodeficiency Syndrome (AIDS) or advanced human immunodeficiency virus disease (CD4 count < 200 cells/mm3).
10. History of clinically significant bleeding disorders (e.g., deficiency of clotting factors, coagulopathy, or platelet disorders), or a history of massive bleeding or severe ecchymosis following placement of intravenous catheters or venipuncture.
11. History of monoclonal antibody (Monoclonal Antibody) infection. 11. Severe adverse reactions related to mAb, and/or a history of severe anaphylactic reactions (e.g., systemic anaphylaxis requiring adrenaline or hospitalization), and/or a history of immune complex disease (type III anaphylaxis) due to monoclonal antibody administration.
12. Any laboratory test values in the screening test kit report that may interfere with the analysis of test results, as determined by the trial administrator.
13. Any condition that may increase AZD0292 clearance (e.g., plasma ablation).
14. Known allergy to antihistamines.
15. Known allergy to any component of AZD0292 or gremubamab.
Previous/concomitant therapy.
16. Treatment with long-term inhaled anti-PsA antibiotics, macrocyclic antibiotics, or DPP-1 (Dipeptidyl Peptidase 1) inhibitors within the past 3 months.
17. Treatment with chronic immunosuppressive therapy (including prednisolone > 5 mg) within the past 3 months. (or equivalent)
17. Receiving an investigational drug indicated for the treatment or prevention of acute exacerbations of bronchiectasis, or expected to receive such an investigational drug during the trial period.
18. Receiving a total dose of human immunoglobulin > 0.8 g/kg (via any route) within 4 weeks prior to administration of the investigational treatment, or scheduled to receive a total dose > 0.8 g/kg within any 4 weeks between administration of the investigational treatment and completion of the trial.
19. Having a total blood volume drawn for any reason exceeding 450 cc within 30 days prior to randomization.
20. Receiving donated blood or plasma within 30 days prior to the screening follow-up visit.
21. Receiving any vaccine within 14 days prior to the first dose of the investigational Medicinal Product (IMP).
22. Having cystic fibrosis (CF) and having undergone Cystic Fibrosis Transmembrane Conductance Regulator (CF) within 3 months prior to screening. Subjects receiving CFTR modulator therapy: Previous/concurrent clinical trial experience:
23. Participants in another clinical trial using the investigational treatment (i.e., the investigational drug) from that trial, and less than 30 days or 5 half-lives of the investigational drug (whichever is longer) since screening.
Note: Subjects participating in observational trials (i.e., trials without drugs, blood tests, or other experimental treatments) are not excluded. Interventional trials without the investigational drug are considered not to constitute exclusion criteria, provided that the blood sampling requirements and scope of the investigational treatment are minimal, and the trial investigator believes that it will not interfere with the sampling and follow-up operations planned for this clinical trial.
Other exclusion criteria:
24. Simultaneous inclusion of another clinical drug interventional trial
25. Lack of a suitable intravenous access for administration of the investigational treatment or serum sampling
26. Pregnant, breastfeeding, or women of childbearing potential who have not used a highly effective method of contraception or abstained from sexual activity for at least 4 weeks prior to administration of the investigational treatment and for at least 6 months after administration of the investigational treatment
27. Known history of drug or alcohol abuse within the past year, and the principal investigator (PI) determines that it may affect the subject's ability to assess safety or comply with all trial requirements
28. Involvement in the planning, execution, supervision, or review of AZD0292 29. AstraZeneca employees, clinical trial center staff, or any other personnel involved in the trial execution, or their family members.
30. If a participant is deemed unlikely to comply with the trial procedures, restrictions, and requirements by the trial administrator, that participant should not participate in the trial.
31. Deprivation of liberty based on administrative or court orders, in emergency situations, or involuntary hospitalization.
1. Presence of a primary pulmonary diagnosis other than bronchiectasis (for subjects concurrently with asthma or chronic obstructive pulmonary disease (COPD), inclusion is permitted if the trial administrator deems bronchiectasis the primary diagnosis).
2. Evidence of active pulmonary tuberculosis or active nontuberculous mycobacterial infection and currently receiving or requiring treatment. Subjects currently receiving treatment for active pulmonary tuberculosis (TB) or nontuberculous mycobacterial infection may be considered for inclusion upon completion of an appropriate course of treatment.
3. Evidence of active allergic bronchopulmonary aspergillosis and currently receiving or requiring treatment.
4. Long-term need for supplemental oxygen. 5. Oxygen may be used for purposes such as walking and relieving shortness of breath after exercise.
6. Life-threatening hemoptysis or coughing up >200 cc of blood within 60 days prior to randomization.
7. Any condition deemed by the trial administrator to significantly increase the risk to the participant's participation, affect the participant's ability to participate, or affect the interpretation of trial data.
8. Current or past 5-year history of malignancy, excluding stable prostate cancer, appropriately treated non-invasive basal cell and squamous cell carcinoma of the skin, and cervical carcinoma in situ that has been treated and has shown apparent treatment success for more than one year prior to inclusion.
9. Acquired Immunodeficiency Syndrome (AIDS) or advanced human immunodeficiency virus disease (CD4 count < 200 cells/mm3).
10. History of clinically significant bleeding disorders (e.g., deficiency of clotting factors, coagulopathy, or platelet disorders), or a history of massive bleeding or severe ecchymosis following placement of intravenous catheters or venipuncture.
11. History of monoclonal antibody (Monoclonal Antibody) infection. 11. Severe adverse reactions related to mAb, and/or a history of severe anaphylactic reactions (e.g., systemic anaphylaxis requiring adrenaline or hospitalization), and/or a history of immune complex disease (type III anaphylaxis) due to monoclonal antibody administration.
12. Any laboratory test values in the screening test kit report that may interfere with the analysis of test results, as determined by the trial administrator.
13. Any condition that may increase AZD0292 clearance (e.g., plasma ablation).
14. Known allergy to antihistamines.
15. Known allergy to any component of AZD0292 or gremubamab.
Previous/concomitant therapy.
16. Treatment with long-term inhaled anti-PsA antibiotics, macrocyclic antibiotics, or DPP-1 (Dipeptidyl Peptidase 1) inhibitors within the past 3 months.
17. Treatment with chronic immunosuppressive therapy (including prednisolone > 5 mg) within the past 3 months. (or equivalent)
17. Receiving an investigational drug indicated for the treatment or prevention of acute exacerbations of bronchiectasis, or expected to receive such an investigational drug during the trial period.
18. Receiving a total dose of human immunoglobulin > 0.8 g/kg (via any route) within 4 weeks prior to administration of the investigational treatment, or scheduled to receive a total dose > 0.8 g/kg within any 4 weeks between administration of the investigational treatment and completion of the trial.
19. Having a total blood volume drawn for any reason exceeding 450 cc within 30 days prior to randomization.
20. Receiving donated blood or plasma within 30 days prior to the screening follow-up visit.
21. Receiving any vaccine within 14 days prior to the first dose of the investigational Medicinal Product (IMP).
22. Having cystic fibrosis (CF) and having undergone Cystic Fibrosis Transmembrane Conductance Regulator (CF) within 3 months prior to screening. Subjects receiving CFTR modulator therapy: Previous/concurrent clinical trial experience:
23. Participants in another clinical trial using the investigational treatment (i.e., the investigational drug) from that trial, and less than 30 days or 5 half-lives of the investigational drug (whichever is longer) since screening.
Note: Subjects participating in observational trials (i.e., trials without drugs, blood tests, or other experimental treatments) are not excluded. Interventional trials without the investigational drug are considered not to constitute exclusion criteria, provided that the blood sampling requirements and scope of the investigational treatment are minimal, and the trial investigator believes that it will not interfere with the sampling and follow-up operations planned for this clinical trial.
Other exclusion criteria:
24. Simultaneous inclusion of another clinical drug interventional trial
25. Lack of a suitable intravenous access for administration of the investigational treatment or serum sampling
26. Pregnant, breastfeeding, or women of childbearing potential who have not used a highly effective method of contraception or abstained from sexual activity for at least 4 weeks prior to administration of the investigational treatment and for at least 6 months after administration of the investigational treatment
27. Known history of drug or alcohol abuse within the past year, and the principal investigator (PI) determines that it may affect the subject's ability to assess safety or comply with all trial requirements
28. Involvement in the planning, execution, supervision, or review of AZD0292 29. AstraZeneca employees, clinical trial center staff, or any other personnel involved in the trial execution, or their family members.
30. If a participant is deemed unlikely to comply with the trial procedures, restrictions, and requirements by the trial administrator, that participant should not participate in the trial.
31. Deprivation of liberty based on administrative or court orders, in emergency situations, or involuntary hospitalization.
The Estimated Number of Participants
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Taiwan
80 participants
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Global
435 participants
