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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07746687
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Aug 5, 2026
Start date
Oct 29, 2026
Status verified
Aug 2026
Primary completion
Sep 11, 2029
Completion
Jul 4, 2030

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

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