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NCT Number: NCT07746687

A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-95597528

Drug

JNJ-95597528 will be administered as subcutaneous (SC) injection.

Placebo

Drug

Placebo will be administered as SC injection.

Primary outcomes

  1. Number of Asthma Exacerbations Through Week 48

    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).

Secondary outcomes

  1. Time to First Asthma Exacerbation Event From Week 0 Through Week 48

    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.

  2. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 12, 24, and 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.

  3. Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48

    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.

  4. Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48

    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).

  5. Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48

    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.

  6. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

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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