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Tests treatment safety and results for Bronchiectasis With Pseudomonas Aeruginosa Colonization
Official title 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
ClinicalTrials.gov ID: NCT07088926
What this study is testing
What is AZD0292?
AZD0292 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bronchiectasis with pseudomonas aeruginosa colonization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations...
- Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
You likely can't join if
- Primary lung diagnosis other than bronchiectasis
- Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving...
- 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...
- AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3)
See the full eligibility 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...
- 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...
- 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...
- Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- Ormond Beach, Florida, United States
- Plantation, Florida, United States
- Rincon, Georgia, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- New Bern, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Tulsa, Oklahoma, United States
- DuBois, Pennsylvania, United States
+ 138 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States; Miami Lakes, Florida, United States and 152 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.