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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma Acute

In brief

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

Key facts

Study ID

NCT06940141

Run by

Connect Biopharm LLC

People needed

160

Starts

2025-08-08

Expected to finish

2026-08-10

Last updated by the study team

2026-08-06

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Amicis Research Center — Valencia, California, United States
• Nemours Children's Hospital - DE — Wilmington, Delaware, United States
• Nemours Children's Health — Jacksonville, Florida, United States
• Pharmax Research of South Florida, Inc. — Miami, Florida, United States
• Columbus Clinical Services, LLC — Miami, Florida, United States
• Nemours Children's Health, Lake Nona — Orlando, Florida, United States
• Health Synergy Clinical Research, LLC — West Palm Beach, Florida, United States
• Primeway Clinical Research Group — Fayetteville, Georgia, United States
• Pivotal Research Solutions — Stonecrest, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Allergy & Asthma Specialists, P.S.C. — Owensboro, Kentucky, United States
• Chesapeake Clinical Research, Inc. — White Marsh, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Clinical Research of Rock Hill — Rock Hill, South Carolina, United States
• Inquest Clinical Research — Baytown, Texas, United States
• Premier Pulmonary Critical Care and Sleep Medicine — Denison, Texas, United States
• DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials — McAllen, Texas, United States
• Vermont Lung Center — Colchester, Vermont, United States
• STAT Research — Caba, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires — Caba, Buenos Aires, Argentina
• Investigaciones en Alergias y Enfermoedades Respiratorias (InAER) — Caba, Buenos Aires, Argentina
• Instituto Ave Pulmo-Fundacion Enfisema — Mar del Plata, Buenos Aires, Argentina
• Leland Stanford Junior University, Stanford Hospital — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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