Last updated 4 days ago
A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma
440 patients around the world
Available in Argentina, United States
Janssen Research & Development, LLC
5Research sites
440Patients around the world
This study is for people with
Asthma
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires
Recruiting
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
Recruiting
Instituto de Medicina Respiratoria IMER - Córdoba
Recruiting
Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza
Recruiting
Ibamédica
Recruiting
StudyREADY-BREATHE
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Asthma
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07746687
