Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation
1 other identifier
interventional
160
6 countries
58
Brief Summary
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
Shorter than P25 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2025
CompletedFirst Posted
Study publicly available on registry
April 23, 2025
CompletedStudy Start
First participant enrolled
August 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2026
ExpectedJune 23, 2026
June 1, 2026
11 months
April 3, 2025
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment failure rate within 28 days after randomization
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
28 days
Secondary Outcomes (9)
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Week 1
Rate of new asthma exacerbations in the 28 days after randomization
28 days
Time to the first new asthma exacerbation in the 28 days after randomization
28 days
Mean CFB in morning/evening asthma symptom score
Week 1, Week 2, and Week 4
Mean CFB in nocturnal awakenings (e-diary)
Week 1, Week 2, and Week 4
- +4 more secondary outcomes
Study Arms (2)
Rademikibart
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Eligibility Criteria
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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, 94304, United States
Amicis Research Center
Valencia, California, 91355, United States
Nemours Children's Hospital - DE
Wilmington, Delaware, 19803, United States
Nemours Children's Health
Jacksonville, Florida, 32207, United States
Pharmax Research of South Florida, Inc.
Miami, Florida, 33175, United States
Columbus Clinical Services, LLC
Miami, Florida, 33215, United States
Nemours Children's Health, Lake Nona
Orlando, Florida, 32827, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407, United States
Primeway Clinical Research Group
Fayetteville, Georgia, 30214, United States
Pivotal Research Solutions
Stonecrest, Georgia, 30038, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503, United States
Vermont Lung Center
Colchester, Vermont, 05446, United States
STAT Research
Caba, Buenos Aires, C1023, Argentina
Hospital Italiano de Buenos Aires
Caba, Buenos Aires, C1199, Argentina
Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
Caba, Buenos Aires, C1425BEN, Argentina
Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, 7600, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
CEMER - Centro Medico de Enfermedades Respiratorias
San Juan Bautista, Buenos Aires, B1602, Argentina
Centro respiratorio Infantil
Rosario, Santa Fe Province, 2000, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, S2000, Argentina
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
INSARES
Mendoza, 5500CCG, Argentina
Centro de Diagnostico y Rehabilitación S.A. -CEDIR
Santa Fe, S3000, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
St George Hospital, South Eastern Sydney Local Health District
Kogarah, New South Wales, 2217, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
Bendigo Health
Bendigo, Victoria, 3550, Australia
JSC "National Center for Lung Health"
Tbilisi, 0101, Georgia
LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112, Georgia
Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, 0159, Georgia
Caucasus Medical Center
Tbilisi, 0159, Georgia
LLC Diacor
Tbilisi, 0159, Georgia
Raymann, LLC
Tbilisi, 0186, Georgia
Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, 11040, Serbia
Clinical Hospital Center Zemun
Belgrade, 11080, Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Institute for Pulmonary Diseases and Tuberculosis Nis
Niš, 18108, Serbia
Health Center Uzice
Užice, 31000, Serbia
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, Greater Manchester, M6 8HD, United Kingdom
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, M23 9QZ, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham
Birmingham, B15 2GW, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD96RJ, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Kings College Hospital NHS Foundation
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2025
First Posted
April 23, 2025
Study Start
August 8, 2025
Primary Completion
July 13, 2026
Study Completion (Estimated)
August 10, 2026
Last Updated
June 23, 2026
Record last verified: 2026-06