Recruiting
Phase 2
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
Condition(s) studied
Bronchiectasis With Pseudomonas Aeruginosa Colonization
Investigational drug(s) / intervention(s)
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
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. Participants who experience an exacerbation during the screening period and receive antibiotic therapy remain eligible for the study if the presence of culture-positive PsA is confirmed prior to randomization.
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 tuberculosis 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 AZD0292 compared to placebo on the rate of moderate or 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.
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