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Clinical Trials List

Protocol NumberD7700C00003
Active

2025-10-01 - 2028-12-31

Phase II

Recruiting7

ICD-10J47.9

Bronchiectasis, uncomplicated

ICD-9494.0

Bronchiectasis without acute exacerbation

A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of Age and Older With Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan Limited

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jer-Hwa Chang Division of Thoracic Medicine
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei- Chang Huang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Horng-Chyuan Lin Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen Chia-Hung Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jung-Yien Chien Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pai-Chien Chou Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Bronchiectasis with chronic Pseudomonas aeruginosa infection

Objectives

This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, multiple-dose study is designed to evaluate the efficacy, safety, and pharmacokinetics of intravenous (IV) administration of AZD0292 in participants with bronchiectasis and chronic Pseudomonas aeruginosa infection who are receiving standard-of-care therapy.

Test Drug

Lyophilized powder for injection

Active Ingredient

AZD0292

Dosage Form

048

Dosage

380 mg/3.8 mL

Endpoints

Evaluate the effect of AZD0292 administered intravenously (IV) every 4 weeks (Q4W) versus placebo on the incidence of moderate to severe pulmonary exacerbations in participants with non-cystic fibrosis bronchiectasis (NCFBE) and chronic Pseudomonas aeruginosa infection.

Inclution Criteria

Participants will be eligible for inclusion in this study only if all of the following criteria are met:

Age

Participants must be ≥ 12 years of age at the time of signing the informed consent/assent form.
– In Taiwan, only adult participants aged ≥ 18 years will be enrolled.

Body Weight
2. Body weight ≥ 35 kg.

Participant Type and Disease Characteristics
3. Clinically diagnosed bronchiectasis, confirmed by computed tomography (CT) demonstrating bronchial dilatation in ≥ 1 lobe.
Note: A CT scan performed within the past 5 years may be used. If not available, a CT scan must be performed during screening to confirm eligibility.

Documented history of ≥ 2 moderate or ≥ 1 severe pulmonary exacerbations requiring antibiotic treatment within the past 12 months.
a) Moderate exacerbation: required oral antibiotics; severe exacerbation: required intravenous (IV) antibiotics and/or hospitalization.
b) Acceptable documentation includes, but is not limited to: hospital records, medical notes, prescription records, or certified true copies of written reports (e.g., X-ray results, pharmacy records).

Clinically stable participants with no bronchiectasis exacerbation within 4 weeks prior to randomization.

At screening, participants must have a Forced Expiratory Volume in 1 Second (FEV₁) (pre- or post-bronchodilator) ≥ 25% of predicted value.

At least one respiratory sample (polymerase chain reaction [PCR] or culture) positive for Pseudomonas aeruginosa (PsA) within 24 months prior to screening.

Sputum culture positive for PsA within 5 weeks prior to randomization.
Participants without a PsA-positive sample within the past 24 months may provide two sputum samples at least 3 weeks apart during the 5-week screening period. If both are PsA-positive, the participant meets inclusion criteria 7 and 8.
If the sputum sample collected at the screening visit is PsA-negative, repeat samples may be submitted during the screening period.

Informed Consent
9. Able and willing to provide signed informed consent/assent, indicating understanding of and compliance with the Informed Consent Form (ICF) and all protocol-specified requirements and restrictions.

Exclusion Criteria

Participants will be excluded from this study if any of the following criteria apply:

Medical Conditions

Primary pulmonary diagnosis other than bronchiectasis.
Participants with concomitant asthma or chronic obstructive pulmonary disease (COPD) may be included only if the investigator considers bronchiectasis to be the primary diagnosis.

Evidence of active pulmonary tuberculosis (TB) or active non-tuberculous mycobacterial (NTM) infection requiring or expected to require treatment.
Participants currently receiving treatment for active TB or NTM infection may be reconsidered for inclusion after completing an appropriate treatment course.

Evidence of active allergic bronchopulmonary aspergillosis (ABPA) requiring or expected to require treatment.

Chronic oxygen therapy dependence.
Use of supplemental oxygen for ambulation or to relieve exertional dyspnea is permitted.

History of life-threatening hemoptysis or ≥ 200 mL of blood expectorated within 60 days prior to randomization.

Any condition that, in the investigator’s judgment, may significantly increase risk, impair study participation, or interfere with data interpretation.

Current or past malignancy within 5 years, except for:
– Stable prostate cancer,
– Adequately treated non-invasive basal cell or squamous cell skin carcinoma, or
– Carcinoma in situ of the cervix treated successfully > 1 year before enrollment.

Acquired immunodeficiency syndrome (AIDS) or advanced HIV infection (CD4 count < 200 cells/mm³).

Clinically significant bleeding disorder (e.g., coagulation factor deficiency, coagulopathy, platelet disorder), or a history of major bleeding/bruising following venipuncture or catheter insertion.

History of severe adverse reactions to monoclonal antibodies (mAbs), including:
– Severe hypersensitivity or anaphylaxis (e.g., requiring epinephrine or hospitalization), and/or
– Immune complex-mediated disease (Type III hypersensitivity) associated with prior mAb therapy.

Laboratory test abnormalities at screening that, in the investigator’s opinion, may interfere with study assessments.

Any condition that may increase AZD0292 clearance, such as plasmapheresis.

Known hypersensitivity to antihistamines.

Known hypersensitivity to AZD0292 or any component of gremubamab.

Prior / Concomitant Therapies

Initiation of long-term inhaled anti–Pseudomonas aeruginosa antibiotics, macrolides, or DPP-1 inhibitors within 3 months prior to screening.

Initiation of chronic immunosuppressive therapy (including prednisolone > 5 mg/day or equivalent) within 3 months prior to screening.

Receipt or planned receipt of investigational products intended for the treatment or prevention of bronchiectasis exacerbations during the study period.

Administration of total immunoglobulin dose > 0.8 g/kg (by any route) within 4 weeks prior to study drug administration, or planned ≥ 0.8 g/kg during any 4-week period throughout the study.

Blood donation or blood draw > 450 mL for any reason within 30 days prior to randomization.

Receipt of blood or plasma transfusion within 30 days prior to screening.

Vaccination within 14 days prior to the first dose of investigational medicinal product (IMP).

Cystic fibrosis (CF) patients who have initiated CFTR modulator therapy within 3 months prior to screening.

Prior / Concurrent Clinical Trial Experience

Participation in another clinical trial involving an investigational product within 30 days or 5 half-lives of the prior investigational drug (whichever is longer).
Participation in observational studies (no drug administration or blood sampling) is allowed. Interventional studies without investigational medicinal products may be allowed if blood sampling and study interventions are minimal and deemed noninterfering by the investigator.

Other Exclusion Criteria

Concurrent enrollment in another interventional clinical trial.

Inadequate venous access for study drug administration or blood sampling.

Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception or abstaining from sexual activity for ≥ 4 weeks before dosing through ≥ 6 months after the last dose.

History of drug or alcohol abuse within the past year that, in the principal investigator’s judgment, may affect participant safety or study compliance.

Employees or immediate family members of AstraZeneca, clinical trial site personnel, or any other individuals involved in the study’s conduct, oversight, or review.

Participants deemed unlikely to comply with study procedures, restrictions, or requirements, as determined by the investigator.

Individuals deprived of liberty by administrative or court order, or hospitalized involuntarily under emergency circumstances.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    435 participants

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