Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults … (NCT06435273) | Clinical Trial Compass
CompletedPhase 2
Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
Canada, Denmark36 participantsStarted 2024-08-05
Plain-language summary
The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in participants with moderate-to-severe asthma.
Study details include:
* The study duration for each participant will be approximately 10 weeks.
* The duration of IMP administration will be approximately 4 weeks.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Documented physician-diagnosed asthma ≥ 12 months prior to screening (Visit 1).
* Participants treated with medium-to-high dose ICS in combination with LABA at a stable dose for at least 2 months prior to Visit 1 (the ICS can be contained within an ICS-LABA fixed dose combination product or as separate inhaled products regularly taken together). Treatment with additional asthma controller therapies (eg, long-acting muscarinic antagonist, leukotriene receptor antagonist) at a stable dose ≥ 2 months prior to Visit 1 is allowed. Treatment with maintenance systemic corticosteroids (oral or injectable) is not allowed.
* A documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1 or ACQ-6 ≥ 1.5 at Visit 1. A severe asthma exacerbation is defined as a worsening of asthma that leads to an inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
* Morning pre-BD FEV1 ≥ 60% predicted at Visit 1.
* Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society/ European Respiratory Society (ATS/ERS) 2019 acceptability criteria.
* Able and willing to undertake bronchoscopy. There should be no absolute contra-indications to bronchoscopy as outlined in the bronchoscopy manual.
* Documented evidence of asthma in the 5 years up to or including Visit 1.
* Able and willing to comply with the requirements of th…
What they're measuring
1
Change from baseline to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings