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 - CLEAR

Study identifier:D7700C00003

ClinicalTrials.gov identifier:NCT07088926

EudraCT identifier:N/A

CTIS identifier:2025-521905-41-00

Will Be Recruiting

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

Medical condition

Bronchiectasis with Pseudomonas Aeruginosa Colonization

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

435

Study type

Interventional

Age

12 Years - n/a

Date

Study Start Date: 12 Nov 2025

Estimated Primary Completion Date: 09 Dec 2027

Estimated Study Completion Date: 14 Jun 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 Jun 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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. 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
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 inhaled 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

No locations available

Arms	Assigned Interventions
Experimental: High-dose High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.	Biological/Vaccine: AZD0292 AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Experimental: Low-dose Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.	Biological/Vaccine: AZD0292 AZD0292 high-dose or low-dose administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
Placebo Comparator: Placebo Placebo administered starting on Day 1, subsequent administrations per schedule of assessments.	Other: Placebo Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]