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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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
INAER - Investigacion en Alergias y Enfermedades Respiratorias
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Instituto de Medicina Respiratoria - Imer
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CórdobaArgentinaRecruiting
Fundacion Scherbovsky
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MendozaArgentinaRecruiting
Instituto De Especialidades De La Salud SRL
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RosarioArgentinaRecruiting
IBAMEDICA Propiedad de IBA Santa Fe S.A.S
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Santa FeArgentinaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Changzhou No 2 Peoples Hospital
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ChangzhouChinaRecruiting
Ningbo Medical Center Lihuili Hospital
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NingboChinaRecruiting
Shanxi Bethune Hospital
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TaiyuanChinaRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
Idaimae Minami4jo Internal Medicine
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SapporoJapanRecruiting
Tokyo Shinagawa Hospital
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Shinagawa CityJapanRecruiting
Boston Specialists
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BostonUnited StatesRecruiting
OK Clinical Research
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EdmondUnited StatesRecruiting
Clinical Research Institute
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MinneapolisUnited StatesRecruiting
Allergy Asthma and Clinical Research Center Martha Tarpay MD
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OklahomaUnited StatesRecruiting
Midwest Clinical Research LLC
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St LouisUnited StatesRecruiting
Equity Medical
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The BronxUnited StatesRecruiting
Allianz Research Institute, Inc.
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WestminsterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.