Actively Recruiting
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Led by Connect Biopharm LLC · Updated on 2026-04-27
160
Participants Needed
52
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
CONDITIONS
Official Title
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physician-diagnosed asthma with duration of �3e�3d 12 months.
- Currently receiving low, medium, or high dose inhaled corticosteroids combined with at least one additional asthma controller medication.
- History of at least one asthma exacerbation requiring systemic corticosteroids.
- For stable participants, documented peripheral blood eosinophil count �3e�3d 250 cells/bcL and/or FeNO �3e�3d 25 ppb.
- Current acute asthma exacerbation needing urgent healthcare treatment.
- Peripheral blood eosinophil count �3e�3d 300 cells/bcL at the time of the acute exacerbation assessment.
- Requires systemic corticosteroid treatment as standard of care during urgent healthcare visit.
- Forced expiratory volume in 1 second (FEV1) �3e�3d 30% predicted.
You will not qualify if you...
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, or uncontrolled hypertension.
- Current or former smoker with smoking history: under 30 years old with �3e�3d 5 pack-years; 30 years or older with �3e�3d 10 pack-years.
- Chronic obstructive pulmonary disease (COPD) or other significant lung diseases besides asthma.
- Known or suspected immunosuppression.
- History of immunodeficiency disorder or hepatitis B or C.
- History of alcohol or drug abuse.
- Recent history of cancer except certain successfully treated cancers like basal cell carcinoma or in situ cervical carcinoma.
- Female participants who are pregnant, breastfeeding, or have a positive pregnancy test before randomization.
- Recent use of drugs modulating type 2 cytokines or biologic drugs for asthma or other diseases.
- Recent live attenuated vaccinations or planned live vaccines during the trial.
- Recent treatment with bronchial thermoplasty.
- Recent use of oral corticosteroids or hospitalization for asthma exacerbation.
- Recent participation in investigational drug studies.
- Recent chest X-ray or CT scan findings inconsistent with asthma.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
2
Amicis Research Center
Valencia, California, United States, 91355
Actively Recruiting
3
Synergy Healthcare
Bradenton, Florida, United States, 34209
Withdrawn
4
Pharmax Research of South Florida, Inc.
Miami, Florida, United States, 33175
Actively Recruiting
5
Columbus Clinical Services, LLC
Miami, Florida, United States, 33215
Actively Recruiting
6
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States, 33407
Actively Recruiting
7
Primeway Clinical Research Group
Fayetteville, Georgia, United States, 30214
Actively Recruiting
8
Pivotal Research Solutions
Stonecrest, Georgia, United States, 30038
Actively Recruiting
9
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
11
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States, 42301
Actively Recruiting
12
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States, 21162
Actively Recruiting
13
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
14
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
15
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
16
Inquest Clinical Research
Baytown, Texas, United States, 77521
Actively Recruiting
17
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States, 75020
Actively Recruiting
18
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States, 78503
Actively Recruiting
19
STAT Research
Caba, Buenos Aires, Argentina, C1023
Actively Recruiting
20
Hospital Italiano de Buenos Aires
Caba, Buenos Aires, Argentina, C1199
Actively Recruiting
21
Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
Caba, Buenos Aires, Argentina, C1425BEN
Actively Recruiting
22
Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, Argentina, 7600
Actively Recruiting
23
Centro respiratorio Infantil
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
24
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina, S2000
Actively Recruiting
25
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
26
INSARES
Mendoza, Argentina, 5500CCG
Actively Recruiting
27
Centro de Diagnostico y Rehabilitación S.A. -CEDIR
Santa Fe, Argentina, S3000
Not Yet Recruiting
28
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
29
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
30
St George Hospital, South Eastern Sydney Local Health District
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
31
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
32
Bendigo Health
Bendigo, Victoria, Australia, 3550
Actively Recruiting
33
JSC "National Center for Lung Health"
Tbilisi, Georgia, 0101
Actively Recruiting
34
LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia, 0112
Actively Recruiting
35
Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, Georgia, 0159
Actively Recruiting
36
Caucasus Medical Center
Tbilisi, Georgia, 0159
Actively Recruiting
37
LLC Diacor
Tbilisi, Georgia, 0159
Actively Recruiting
38
Raymann, LLC
Tbilisi, Georgia, 0186
Actively Recruiting
39
Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, Serbia, 11040
Actively Recruiting
40
Clinical Hospital Center Zemun
Belgrade, Serbia, 11080
Not Yet Recruiting
41
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Serbia, 21204
Actively Recruiting
42
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
43
Institute for Pulmonary Diseases and Tuberculosis Nis
Niš, Serbia, 18108
Actively Recruiting
44
Health Center Uzice
Užice, Serbia, 31000
Actively Recruiting
45
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, Greater Manchester, United Kingdom, M6 8HD
Actively Recruiting
46
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, United Kingdom, M23 9QZ
Actively Recruiting
47
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
48
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
49
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
50
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom, BD96RJ
Actively Recruiting
51
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
52
Kings College Hospital NHS Foundation
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
R
Radha Adivikolanu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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