Asthma
Conditions
Brief summary
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).
Interventions
DRUGJNJ-95597528
JNJ-95597528 will be administered as subcutaneous (SC) injection.
DRUGPlacebo
Placebo will be administered as SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline * Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of bronchodilator responsiveness at screening and baseline: Post-bronchodilator forced expiratory volume in 1 second (FEV1) increases by greater than or equal to (\>=) 200 milliliter (mL) and \>=12 percent (%) of pre- bronchodilator value, or increase in peak expiratory flow (PEF) \>=20%, if spirometry is not available; b. Demonstrated increase in lung function within the past 3 years after \>=4 weeks of daily inhaled corticosteroids (ICS)-containing treatment, shown by: increase from baseline FEV1 by \>=12% and \>=200 mL, or increase in PEF by \>=20%; c. Positive bronchial provocation test within the past 3 years, as defined by: \>=20% decrease from baseline in FEV1 with standard doses of methacholine, or \>=15% decrease from baseline in FEV1 with standardized hyperventilation, hypertonic saline or mannitol challenge, or decrease from baseline in FEV1 of \>10% and \>200 mL with standardized exercise challenge * Inhaled corticosteroid: Prescribed medium- or high-dose ICS for at least 1 year and a stable dose of medium- or high-dose ICS for at least 3 months prior to the screening visit per GINA 2025: • High-dose ICS is defined as a total daily dose \>=500 microgram (mcg) fluticasone propionate or equivalent, • Medium-dose ICS is defined as a total daily dose \>=250 to 500 mcg fluticasone propionate or equivalent * Additional controller medication: Must be on a stable dose of at least 1 additional maintenance asthma controller, in addition to ICS, per GINA 2025, for at least 3 months prior to screening (for example, long-acting beta-agonist \[LABA\], long-acting muscarinic antagonist \[LAMA\] \[can be combined with ICS in 1 inhaler or can be separate inhalers\], leukotriene receptor antagonist \[LTRA\]) * Asthma control questionnaire, 5-item (ACQ-5) score \>=1.5 at the screening visit and the baseline visit
Exclusion criteria
* History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment * Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts * Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling * Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma * Current smokers or former smokers with a smoking history \>=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Asthma Exacerbations Through Week 48 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Asthma Exacerbation Event From Week 0 Through Week 48 | 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. |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 12, 24, and 48 | 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. |
| Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48 | 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. |
| Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48 | 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). |
| Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48 | 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. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed