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READY-BREATHENCT07746687

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Trial sites expanded: 0 → 19 locations
    • Start date changed from estimate of Oct 29, 2026 to Oct 5, 2026
  2. Study completion date: Jul 4, 2030 to Jul 1, 2030
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 6 entries
  3. Start date: Sep 23, 2026 to Oct 29, 2026v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Asthma Exacerbations Through Week 48
Timeframe: Up to Week 48

Secondary (6)

Time to First Asthma Exacerbation Event 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
Change from Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Weeks 2, 12, 24, and 48
Change From Baseline in Asthma Control Questionnaire, 5-item (ACQ-5) At Week 48
Mean Change From Baseline in the 7-Day Mean Daily Asthma Daily Diary score at Week 48
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Arms and interventions

Group 1: JNJ-95597528: Dose 1Experimental

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

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

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.

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

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.

Group 4: PlaceboPlacebo comparator

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

Drugs: JNJ-95597528, Placebo

Sites

19 sites in 5 countries

United States 7, Argentina 5, China 4, Japan 2, Israel 1