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Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Rademikibart in prefilled syringe (combination product), Matching placebo in prefilled syringe (drug)
How long the study runs: Study runs about 12 months (dates as stated)
About the drug or intervention: Rademikibart in prefilled syringe — combination product: Participants receive 600 mg (4mL) of rademikibart administered subcutaneously. · Matching placebo in prefilled syringe — drug: Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 12 Years to 75 Years
Who: All
Number of participants: 160
Started: 2025-08-08
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for asthma acute
• Phase2 - 160 participants
• This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Who can take part?

• Ages 12 Years to 75 Years
• Diagnosed with asthma acute

Where?

• Salford - Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
• Wythenshawe - Medicines Evaluation Unit Ltd.
• Norwich - Norfolk and Norwich University Hospital NHS Foundation Trust
• Birmingham - University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham
• +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

More detail

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.

Asthma Acute

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years - 75 Years
Who can join: All genders

Biomarkers mentioned

has a positive

Treatment history

Treatments you must have had:

✓ experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids
✓ a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb

What the study is looking for

✓Physician-diagnosed asthma with duration of ≥12 months.
✓Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma...
✓Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
✓For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250...
✓Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.

Who cannot take part

✗Regular use of immunosuppressive medication.
✗Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
✗Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years...
✗COPD and other clinically significant lung disease other than asthma.
✗Known or suspected history of immunosuppression.

See the full criteria

Inclusion Criteria: * Physician-diagnosed asthma with duration of ≥12 months. * Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication. * Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids. * For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. * Current acute asthma exacerbation requiring an urgent healthcare visit for treatment. * Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation. * Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation. * FEV1 ≥30% predicted. Exclusion Criteria: * Regular use of immunosuppressive medication. * Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. * Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years * COPD and other clinically significant pulmonary disease other than asthma. * Known or suspected history of immunosuppression. * History of known immunodeficiency disorder or hepatitis B or C. * History of alcohol abuse and/or drug abuse. * Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy or other malignancies treated with apparent success with curative therapy. * Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization. * Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate). * Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases. * Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial. * Participants that have been recently treated with bronchial thermoplasty. * Recent treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of asthma. * Recent receipt of any investigational nonbiologic drug. * A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population. The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.