Can a new injection tame severe asthma?
NCT ID NCT07746687
First seen Aug 05, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This trial is testing an experimental drug called JNJ-95597528 in adults with moderate to severe asthma that is not well controlled by current treatments. The goal is to see if the drug can reduce the number of asthma attacks over 48 weeks compared to a placebo. Participants will receive either the drug or a placebo as a subcutaneous injection, and researchers will monitor lung function and symptom changes. The study aims to determine whether this new approach could offer a better way to manage asthma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JNJ-95597528, an experimental drug given as a subcutaneous injection
- What this could lead to
- If successful, this could lead to a new treatment option that reduces asthma attacks and improves symptom control for people with moderate to severe asthma.
- What could go wrong
- This is an early-stage trial, so the drug may not prove more effective than placebo. Possible side effects are not yet fully known, and results may not apply to all asthma patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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