NCT07746687RecruitingPhase 2
A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 31 Jul 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 11 Sept 2029
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Asthma
- NCT number
- NCT07746687
- EU CT number
- 2026-526262-24-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 440
- From 5 Oct 2026 to the primary completion date, 11 Sept 2029
- 19 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- 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
Lab values
- Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INAER - Investigacion en Alergias y Enfermedades Respiratorias Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Instituto de Medicina Respiratoria - Imer Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Fundacion Scherbovsky Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Instituto De Especialidades De La Salud SRL Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| IBAMEDICA Propiedad de IBA Santa Fe S.A.S Coordinator of this site? Confirm its status | Santa Fe | Argentina | Recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Changzhou No 2 Peoples Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Idaimae Minami4jo Internal Medicine Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tokyo Shinagawa Hospital Coordinator of this site? Confirm its status | Shinagawa City | Japan | Recruiting |
| Boston Specialists Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| OK Clinical Research Coordinator of this site? Confirm its status | Edmond | United States | Recruiting |
| Clinical Research Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Allergy Asthma and Clinical Research Center Martha Tarpay MD Coordinator of this site? Confirm its status | Oklahoma | United States | Recruiting |
| Midwest Clinical Research LLC Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Equity Medical Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Allianz Research Institute, Inc. Coordinator of this site? Confirm its status | Westminster | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.