AZD0292 for bronchiectasis with chronic Pseudomonas colonization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, randomized, placebo-controlled trial evaluating the efficacy, safety, and pharmacokinetics of AZD0292 administered IV in adults 18 years and older with bronchiectasis and chronic PsA colonization. Participants must have a history of frequent pulmonary exacerbations and stable disease at randomization. The study compares AZD0292 to placebo, with safety and PK as key secondary measures alongside exacerbation outcomes. Primary analysis will assess reduction in exacerbations, while monitoring adverse events and drug exposure in Chinese patients at multiple sites including Anyang and Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be ≥ 18 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
* Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, 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

Where it's running

• Research Site
  Anyang, China Recruiting
• Research Site
  Beijing, China Recruiting
• Research Site
  Beijing, China Recruiting
• Research Site
  Beijing, China Recruiting
• Research Site
  Changsha, China Recruiting
• Research Site
  Chengdu, China Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.