The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
440
JNJ-95597528 will be administered as subcutaneous (SC) injection.
Placebo will be administered as SC injection.
Number of Asthma Exacerbations Through Week 48
Participant who experiences intercurrent events (ICEs) in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have an asthma exacerbation. An asthma exacerbation is defined as a worsening of asthma that requires a medical intervention and/or results in death. A worsening of asthma is defined as: worsening of asthma signs/symptoms; increased use of 'as needed' reliever medication; deterioration of lung function that is, peak expiratory flow, forced expiratory volume in 1 second (FEV1).
Time frame: Up to Week 48
Time to First Asthma Exacerbation Event From Week 0 Through Week 48
Time to first asthma exacerbation event from Week 0 through Week 48 will be reported. A participant is considered to have an asthma exacerbation if the participant experiences ICEs in categories 5 or 6 after treatment initiation and prior to Week 48.
Time frame: From Week 0 Through Week 48
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 12, 24, and 48
Change from baseline in pre-bronchodilator FEV1 at Weeks 2, 12, 24, and 48, where a participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have a zero change from baseline in pre-BD FEV1 at Weeks 2, 12, 24, and 48 will be reported.
Time frame: Baseline, Week 2, 12, 24, and 48
Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48
Change from baseline in FeNO at Weeks 2, 12, 24, and 48, where a participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have zero change from baseline in FeNO at Weeks 2, 12, 24, and 48 will be reported. FeNO is a non-invasive breath test that provides an objective measure of type 2 airway inflammation. High FeNO levels have been shown to predict increased risk of acute exacerbations in participants with moderate to severe asthma.
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Time frame: Baseline, Week 2, 12, 24, and 48
Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48
Change from baseline in ACQ-5 at Week 48, where a participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have zero change from baseline will be reported. The ACQ is a validated, 5-item, patient-reported tool used to measure asthma control and treatment effectiveness over the past week. Each item has with 7 response categories ranging from 0 to 6. The ACQ-5 is scored by computing the average of the 5 items. The final score ranges from 0 (well-controlled) to 6 (extremely poorly controlled).
Time frame: Baseline, Week 48
Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48
Mean change from baseline in the 7-day mean daily asthma daily diary score at Week 48 will be reported. A participant experiencing ICEs in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have zero change from baseline.
Time frame: Baseline, Week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, except: hospitalizations not intended to treat an acute illness or AE; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: Up to 90 weeks