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RECRUITING

NCT07088926

PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

435

Start Date

2025-11-06

Completion Date

2028-06-14

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Bronchiectasis With Pseudomonas Aeruginosa Colonization

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.

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

Locations (182)

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Orange, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami Lakes, Florida, United States

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Naples, Florida, United States

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Ormond Beach, Florida, United States

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Plantation, Florida, United States

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Rincon, Georgia, United States

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Kansas City, Kansas, United States

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Ann Arbor, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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New York, New York, United States

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New Bern, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Tulsa, Oklahoma, United States

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DuBois, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Rock Hill, South Carolina, United States

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Austin, Texas, United States

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Mansfield, Texas, United States

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Ciudad de Buenos Aires, Argentina

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Florida, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Birtinya, Australia

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Macquarie University, Australia

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South Brisbane, Australia

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Sint-Niklaas, Belgium

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Blumenau, Brazil

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Campinas, Brazil

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Curitiba, Brazil

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Curitiba, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Salvador, Brazil

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São José dos Campos, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Ajax, Ontario, Canada

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Stoney Creek, Ontario, Canada

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Québec, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Concepción, Chile

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Santiago, Chile

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Santiago, Chile

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Talca, Chile

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Viña del Mar, Chile

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Aalborg, Denmark

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Aarhus N, Denmark

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Hvidovre, Denmark

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Odense C, Denmark

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Roskilde, Denmark

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Brest, France

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Créteil, France

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Marseille, France

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Montpellier, France

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Paris, France

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Pessac, France

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Strasbourg, France

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Toulouse, France

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Darmstadt, Germany

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Essen, Germany

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Frankfurt, Germany

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Halle, Germany

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Hanover, Germany

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Konstanz, Germany

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München, Germany

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München-Pasing, Germany

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Ioannina, Greece

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Larissa, Greece

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Pátrai, Greece

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Thessaloniki, Greece

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Ashkelon, Israel

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Milan, Italy

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Palermo, Italy

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Pavia, Italy

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Perugia, Italy

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Roma, Italy

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Rozzano, Italy

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Torrette, Italy

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Bunkyō City, Japan

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Gifu, Japan

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Hiratsuka-shi, Japan

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Kamogawa-shi, Japan

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Kiyose-shi, Japan

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Kiyose-shi, Japan

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Kurashiki-shi, Japan

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Miyazaki, Japan

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Nagasaki, Japan

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Ogi, Japan

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Shinjuku-ku, Japan

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Shinjuku-ku, Japan

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Urayasu-shi, Japan

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Bandar Puncak Alam, Malaysia

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Kuala Lumpur, Malaysia

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Sibu, Malaysia

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Amsterdam, Netherlands

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Rotterdam, Netherlands

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Zutphens, Netherlands

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Bellavista, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Iloilo City, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Tondo, Philippines

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Anyang-si, South Korea

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Cheongju-si, South Korea

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Daegu, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Ulsan, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Benalmádena, Spain

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Madrid, Spain

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Madrid, Spain

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Mérida, Spain

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Patraix, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Bang Kra So, Thailand

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Bangkok, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

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Pathum Thani, Thailand

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Diyarbakır, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Zeytinburnu, Turkey (Türkiye)

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Belfast, United Kingdom

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Birmingham, United Kingdom

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Brighton, United Kingdom

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Cambridge, United Kingdom

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Dundee, United Kingdom

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Edinburgh, United Kingdom

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Exeter, United Kingdom

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Liverpool, United Kingdom

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Manchester, United Kingdom

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Can Tho, Vietnam

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Haiphong, Vietnam

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Hanoi, Vietnam

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Hà Nội, Vietnam

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Ho Chi Minh City, Vietnam

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Huế, Vietnam

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (182)