Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
440 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe asthma who need better control of their symptoms. Participants will compare the effects of the study drug JNJ-95597528 to a placebo over time.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroidsAdditional asthma controller medication
You may be able to join if
I have moderate to severe asthma.
I have been on medium- or high-dose inhaled corticosteroids for at least 1 year.
I have been stable on my asthma medications for at least 3 months.
I have a score of 1.5 or higher on the asthma control questionnaire.
You may not be able to join if
I have a serious health condition that affects my lungs or heart.
I have been hospitalized or needed emergency treatment for my asthma in the last 2 weeks.
I smoke or have a significant history of smoking.
I have had a bad reaction to specific asthma medications that act on interleukin signaling.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Locations
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Status
Eligibility Criteria
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 br…
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
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