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
AZD0292: AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Placebo: Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Study summary
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Participant must be ≥ 12 years of age at the time of signing the informed consent/assent
2. Weight ≥ 35 kg
3. 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.
4. 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
5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
8. 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.
9. 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:
1. Primary lung diagnosis other than bronchiectasis
2. 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
3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
5. 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
6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3)
7. 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
8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
9. Chronic immunosuppressive therapy (including prednisolone \> 5 mg or equivalent) newly initiated within the last 3 months
10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening
12. 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
Primary outcome measure(s)
Annualized rate of exacerbations over a variable follow-up time — Min 28 weeks, max 52 weeks 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.
Trial sites (186)
Facility
City
Region
Status
Research Site
Orange
California
Recruiting
Research Site
San Francisco
California
Recruiting
Research Site
Denver
Colorado
Not Yet Recruiting
Research Site
Washington D.C.
District of Columbia
Recruiting
Research Site
Jacksonville
Florida
Recruiting
Research Site
Miami Lakes
Florida
Terminated
Research Site
Naples
Florida
Recruiting
Research Site
Ormond Beach
Florida
Recruiting
Research Site
Plantation
Florida
Recruiting
Research Site
Rincon
Georgia
Recruiting
Research Site
Kansas City
Kansas
Recruiting
Research Site
Ann Arbor
Michigan
Recruiting
Research Site
Detroit
Michigan
Withdrawn
Research Site
Rochester
Minnesota
Withdrawn
Research Site
St Louis
Missouri
Recruiting
Research Site
New York
New York
Recruiting
Research Site
New Bern
North Carolina
Recruiting
Research Site
Winston-Salem
North Carolina
Not Yet Recruiting
Research Site
Tulsa
Oklahoma
Withdrawn
Research Site
DuBois
Pennsylvania
Withdrawn
Research Site
Philadelphia
Pennsylvania
Recruiting
Research Site
Charleston
South Carolina
Recruiting
Research Site
Rock Hill
South Carolina
Withdrawn
Research Site
Austin
Texas
Withdrawn
Research Site
Mansfield
Texas
Recruiting
Research Site
Ciudad de Buenos Aires
Argentina
Recruiting
Research Site
Florida
Argentina
Recruiting
Research Site
Rosario
Argentina
Recruiting
Research Site
San Miguel de Tucumán
Argentina
Recruiting
Research Site
Birtinya
Australia
Recruiting
Research Site
Macquarie University
Australia
Recruiting
Research Site
South Brisbane
Australia
Recruiting
Research Site
Ghent
Belgium
Recruiting
Research Site
Leuven
Belgium
Recruiting
Research Site
Liège
Belgium
Recruiting
Research Site
Sint-Niklaas
Belgium
Recruiting
Research Site
Blumenau
Brazil
Recruiting
Research Site
Campinas
Brazil
Recruiting
Research Site
Curitiba
Brazil
Recruiting
Research Site
Curitiba
Brazil
Recruiting
+ 146 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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