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

Prior treatment

• Regular use of immunosuppressive medication.
• 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).
• 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.

Other illness

• Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
• 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.
• Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.

Age

• 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

Other

• Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
• 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.

• 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.