Recruiting
Phase 2

JNJ-95597528

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07746687

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

JNJ-95597528

Placebo

Study Details

Brief summary:

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).

Conditions

Asthma

Study ID

NCT07746687

Start date

Oct 5, 2026

Status verified date

Nov, 2026

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Sep 11, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: JNJ-95597528: Dose 1

Participants will receive JNJ-95597528 Dose 1 at Weeks 0, 2, 12, 24 and 36.

experimental: Group 2: JNJ-95597528: Dose 2 and Dose 3

Participants will receive JNJ-95597528 Dose 2 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 3 at Weeks 12, 24 and 36.

experimental: Group 3: JNJ-95597528: Dose 4 and 5

Participants will receive JNJ-95597528 Dose 4 at Week 0, placebo at Week 2 then JNJ-95597528 Dose 5 at Weeks 12, 24 and 36.

placebo comparator: Group 4: Placebo

Participants will receive matching placebo doses at Weeks 0, 2, 12, 24, and 36.

Interventions

JNJ-95597528

JNJ-95597528 will be administered as subcutaneous (SC) injection.

Placebo

Placebo will be administered as SC injection.

Primary outcome measure

  • Number of Asthma Exacerbations Through Week 48 [ Time Frame: Up to Week 48 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Allianz Research Institute, Inc.

Recruiting

Westminster, California, United States, 92683

Boston Specialists

Recruiting

Boston, Massachusetts, United States, 02111

Clinical Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55402

Midwest Clinical Research LLC

Recruiting

St Louis, Missouri, United States, 63141

Equity Medical

Recruiting

The Bronx, New York, United States, 10455

OK Clinical Research

Recruiting

Edmond, Oklahoma, United States, 73034

Allergy Asthma and Clinical Research Center Martha Tarpay MD

Recruiting

Oklahoma, Texas, United States, 73120

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Nov 3, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.