JNJ-95597528
DrugJNJ-95597528 will be administered as subcutaneous (SC) injection.
NCT Number: NCT07746687
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).
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-95597528 will be administered as subcutaneous (SC) injection.
Placebo will be administered as SC injection.
Time frame: Up to 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: 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: Baseline, Week 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 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.
Time frame: Baseline, 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 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: Up to 90 weeks
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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Inadequately Controlled Moderate to Severe Asthma
Acronym: READY-BREATHE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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