Test of JNJ-95597528 vs placebo in adults with moderate to severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, blinded study comparing JNJ-95597528 to placebo in adults with inadequately controlled moderate to severe asthma. Participants must be medically stable and meet objective criteria showing variable airway obstruction or recent improvement with inhaled corticosteroids. The study will assess lung function changes and safety over a specified treatment period. Investigators will monitor FEV1, PEF, and other safety parameters to determine if the drug improves respiratory outcomes. Locations include sites in California, Massachusetts, and Minnesota under Janssen Research & Development leadership.

Why it matters

Who can join: the full rules

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

Where it's running

• Allianz Research Institute, Inc.
  Westminster, California, United States Recruiting
• Boston Specialists
  Boston, Massachusetts, United States Recruiting
• Clinical Research Institute
  Minneapolis, Minnesota, United States Recruiting
• Midwest Clinical Research LLC
  St Louis, Missouri, United States Recruiting
• Equity Medical
  The Bronx, New York, United States Recruiting
• OK Clinical Research
  Edmond, Oklahoma, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.