Recruiting NCT07088926

A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

Phase II Interventional Bronchiectasis With Pseudomonas Aeruginosa Colonization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AZD0292, Placebo.
Who it may be relevant to: Registry conditions: Bronchiectasis With Pseudomonas Aeruginosa Colonization. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +20
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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

This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older.

The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.

Interventions

Biological AZD0292
AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Other Placebo
Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

Primary outcome measures

Annualized rate of exacerbations over a variable follow-up time [Time frame: Min 28 weeks, max 52 weeks]

Secondary outcome measures (7)

Annualized rate of severe exacerbations over a variable follow-up time [Time frame: Min 28 weeks, max 52 weeks]
Change from baseline in QOL-B-RSS [Time frame: Over the observation period (Week 0 to Final Dose+4 weeks)]
Change from baseline in SGRQ score [Time frame: Over the observation period (Week 0 to Final Dose +4 weeks)]
Time to first moderate or severe exacerbation [Time frame: Through study completion (Final Dose +24 weeks)]
Serum PK Concentrations [Time frame: At specified timepoints between Week 0 and Final Dose+12 weeks]
Incidence of ADA and ADA titers to AZD0292 [Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks]
Incidence of AEs, SAEs, AESIs and MAAEs [Time frame: Occurrence of AEs; first dose through 12 weeks after last study intervention administration. Occurrence of SAEs, AESIs, and MAAEs; through study completion (Final Dose+24 weeks)]

Eligibility criteria

Inclusion 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Prevention