A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

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

Secondary outcome measures (6)

• Time to First Asthma Exacerbation Event From Week 0 Through Week 48 [Time frame: From Week 0 Through Week 48]
• Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 12, 24, and 48 [Time frame: Baseline, Week 2, 12, 24, and 48]
• Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48 [Time frame: Baseline, Week 2, 12, 24, and 48]
• Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48 [Time frame: Baseline, Week 48]
• Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48 [Time frame: Baseline, Week 48]
• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 90 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746687 · 95597528ASH2001 · 2026-526262-24-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗