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

NCT07746687 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 95597528ASH20012026-526262-24-00
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Asthma Exacerbations Through Week 48

  Participant who experiences intercurrent events (ICEs) in categories 5 or 6 after treatment initiation and prior to Week 48 is considered to have an asthma exacerbation. An asthma exacerbation is defined as a worsening of asthma that requires a medical intervention and/or results in death. A worsening of asthma is defined as: worsening of asthma signs/symptoms; increased use of 'as needed' reliever medication; deterioration of lung function that is, peak expiratory flow, forced expiratory volume in 1 second (FEV1).

  Up to Week 48

Secondary Outcomes (6)

• Time to First Asthma Exacerbation Event From Week 0 Through Week 48

  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

  Baseline, Week 2, 12, 24, and 48

• Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48

  Baseline, Week 2, 12, 24, and 48

• Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48

  Baseline, Week 48

• Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48

  Baseline, Week 48

Study Arms (4)

Group 1: JNJ-95597528: Dose 1

EXPERIMENTAL

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

Drug: JNJ-95597528

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

EXPERIMENTAL

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.

Drug: JNJ-95597528; Drug: Placebo

Group 3: JNJ-95597528: Dose 4 and 5

EXPERIMENTAL

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.

Drug: JNJ-95597528; Drug: Placebo

Group 4: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JNJ-95597528 DRUG

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

Group 1: JNJ-95597528: Dose 1; Group 2: JNJ-95597528: Dose 2 and Dose 3; Group 3: JNJ-95597528: Dose 4 and 5

Placebo DRUG

Placebo will be administered as SC injection.

Group 2: JNJ-95597528: Dose 2 and Dose 3; Group 3: JNJ-95597528: Dose 4 and 5; Group 4: Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 23, 2026
• Primary Completion (Estimated): September 11, 2029
• Study Completion (Estimated): July 4, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share