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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 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

    2026/09/14

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 Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

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
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Horng-Chyuan Lin
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Bronchiectasis With Pseudomonas Aeruginosa Colonization

Objectives

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

Test Drug

AZD0292

Active Ingredient

AZD0292

Dosage Form

Lyophilized powder for injection

Dosage

380 mg/3.8 mL

Endpoints

Annualized rate of exacerbations over a variable follow-up time To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to-severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA. Min 28 weeks, max 52 weeks

Inclution Criteria

Participant must be ≥ 12 years of age at the time of signing the informed consent/assent
Weight ≥ 35 kg
Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.
Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.
Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria

Primary lung diagnosis other than bronchiectasis
Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy
Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
AIDS or Advanced human immunodeficiency virus disease (CD4 count of < 200 cells/mm3)
History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration
Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months
Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening
Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    435 participants

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