A trial to learn how well AZD0292 works, how safe it is, and how it moves throughout the body over time in people with bronchiectasis and chronic PsA colonization

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

16 Dec 2025 → ongoing

Decision date (initial)

2025-11-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 7

1. To evaluate the effect of AZD0292 compared to placebo on severe exacerbations in participants with NCFBE and chronic colonization with PsA
2. To evaluate the effect of AZD0292 compared to placebo on QoL quality of life, as assessed by the QoL-B Respiratory Symptom Scale Score (QoL-B-RSS) over the observation period
3. To evaluate the effect of AZD0292 compared to placebo on QoL quality of life, as assessed by the SGRQ respiratory domain over the observation period
4. To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.
5. To evaluate the PK of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA.
6. To evaluate the immunogenicity of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA.
7. To assess the safety of AZD0292 compared with placebo in participants with bronchiectasis and chronic colonization with PsA.

Conditions and MedDRA coding

Bronchiectasis with chronic pseudomonas aeruginosa colonization

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participant must be ≥ 18 years of age at the time of signing the informed consent
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 a) 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 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion criteria 12

1. Primary lung diagnosis other than bronchiectasis
2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Active tuberculosis may be suspected if a participant has a cough for more than 2 weeks with concurrent fever, night sweats, weight loss, or hemoptysis. Investigation for active or latent TB, with interferon gamma release assay (IGRA) and/or chest X-ray, should be considered if deemed clinically indicated by the Investigator. 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 of childbearing potential 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualized rate of exacerbations over a variable follow-up time

Secondary endpoints 7

1. Annualized rate of severe exacerbations over a variable follow-up time
2. Change from baseline in QoL-B-RSS
3. Change from baseline in SGRQ score
4. Time to first moderate or severe exacerbation and Time to first severe exacerbation
5. Serum PK concentrations of AZD0292 at all collected timepoints
6. Incidence of ADA to AZD0292 and ADA titers of AZD0292 at all collected timepoints
7. Occurrence of AEs collected from the first dose through 12 weeks after last IMP administration and SAEs, AESIs, and MAAEs, collected throughout the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

8 EU/EEA countries · 50 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 41 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications