Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
NCT ID: NCT06940141
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2025-08-08
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rademikibart
Rademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Placebo
Matching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Interventions
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Rademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Matching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 OCS 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.
12 Years
75 Years
ALL
No
Sponsors
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Connect Biopharm LLC
INDUSTRY
Responsible Party
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Locations
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Amicis Research Center
Valencia, California, United States
Synergy Healthcare
Bradenton, Florida, United States
Pharmax Research of South Florida, Inc.
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, 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 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
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
STAT Research
Caba, Buenos Aires, Argentina
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
St George Hospital, South Eastern Sydney Local Health District
Kogarah, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
"NCTLD National Center for Tuberculosis and Lung Disease" JSC
Tbilisi, , Georgia
LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, , Georgia
Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, , Georgia
Caucasus Medical Center
Tbilisi, , Georgia
LLC Diacor
Tbilisi, , Georgia
Raymann, LLC
Tbilisi, , Georgia
Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, , Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Institute for Pulmonary Diseases and Tuberculosis Nis
Niš, , Serbia
Health Center Uzice
Užice, , Serbia
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, Greater Manchester, United Kingdom
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Radha Adivikolanu
Role: primary
Other Identifiers
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CBP-201-206
Identifier Type: -
Identifier Source: org_study_id
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