RecruitingPhase 2interventionalRules rewrite

Phase 2: testing JNJ-95597528 for Asthma

This study wants to assess how well JNJ-95597528 works when compared to dummy treatment (placebo) in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).

Official registry: https://clinicaltrials.gov/study/NCT07746687 · Janssen Research & Development, LLC · enrollment listed as 440

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are JNJ-95597528, or Placebo. The registry lists allocation as randomized. This study wants to assess how well JNJ-95597528 works when compared to dummy treatment (placebo) in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).

They plan to enroll about 440 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: JNJ-95597528, Placebo

Primary outcome (registry wording): Number of Asthma Exacerbations Through Week 48

Who it is for (from inclusion criteria)

Ages 18 Years to 85 Years
Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline
Asthma control questionnaire, 5-item (ACQ-5) score \>=1.5 at the screening visit and the baseline visit

Who the registry excludes

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 how well it works 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

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

19 listed

Allianz Research Institute, Inc. — Westminster, California (recruiting)
Boston Specialists — Boston, Massachusetts (recruiting)
Clinical Research Institute — Minneapolis, Minnesota (recruiting)
Midwest Clinical Research LLC — St Louis, Missouri (recruiting)
Equity Medical — The Bronx, New York (recruiting)
OK Clinical Research — Edmond, Oklahoma (recruiting)
Allergy Asthma and Clinical Research Center Martha Tarpay MD — Oklahoma, Texas (recruiting)

+ 12 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07746687 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07746687?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07746687?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary