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Purpose

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

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
D7700C00003 is a multicenter, randomized, Phase IIb, double-blind, placebo-controlled, parallel, multidose study to evaluate the efficacy, safety, and PK of AZD0292 compared with placebo in participants with bronchiectasis and chronic PsA colonization. The study will enroll up to 435 bronchiectasis participants.
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Participants, Investigators, site staff, and AstraZeneca study staff who are involved in the treatment or clinical evaluation and monitoring of the participants will remain blinded to each participant's treatment assignment throughout the course of the study. As AZD0292 and placebo are visually distinct prior to dose preparation, an unblinded pharmacist (or designee, in accordance with local and institutional regulations) will be responsible for the handling and dose preparation of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense following randomization.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High-dose 		High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
  • Biological: 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: 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.

Recruiting Locations

Research Site
Jacksonville, Florida 32209

Research Site
Naples, Florida 34102

Research Site
Ormond Beach, Florida 32174

Research Site
Plantation, Florida 33324

Research Site
Rincon, Georgia 31326

Research Site
Kansas City, Kansas 66160

Research Site
St Louis, Missouri 63130

Research Site
New York, New York 10016

Research Site
Rock Hill, South Carolina 29732

Research Site
Mansfield, Texas 76063

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA. This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older. The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.