Actively Recruiting
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Led by Connect Biopharm LLC · Updated on 2026-04-27
160
Participants Needed
51
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
CONDITIONS
Official Title
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physician-diagnosed COPD lasting 12 months or more
- At least one COPD exacerbation treated with systemic corticosteroids
- Stable participants must have historical blood eosinophil count of 250 cells/µL or higher and/or FeNO 25 ppb or higher
- Current or former smoker with a smoking history of at least 10 pack-years
- Currently experiencing an acute COPD exacerbation requiring urgent healthcare visit
- Blood eosinophil count of 300 cells/µL or higher during the current exacerbation
- Requires systemic corticosteroids as standard treatment for the current exacerbation
You will not qualify if you...
- Regular use of immunosuppressive medication within 12 weeks or 5 half-lives before randomization
- Current or past diagnosis of asthma or Asthma COPD Overlap Syndrome
- Other respiratory disorders affecting safety or study results
- Unstable heart conditions including ischemic heart disease, cardiomyopathy, heart failure (Class III or IV), uncontrolled hypertension, or cardiac arrhythmias
- Stroke, transient ischemic attack, or cardiovascular hospitalization within 6 months before screening
- Known or suspected immunosuppression or immunodeficiency disorders, including hepatitis B or C
- History of alcohol or drug abuse
- Recent cancer history except certain treated skin or cervical cancers
- Chronic use of long-term oxygen therapy over 15 hours per day
- Use of long-term macrolide antibiotics
- Current exacerbation treated more than 48 hours before screening
- Chest X-ray or CT scan showing significant abnormalities or infections not related to COPD
- Pregnant or breastfeeding women or those with positive pregnancy test
- Recent use of drugs affecting type 2 cytokines or biologics for COPD or other diseases
- Recent live vaccinations within 4 weeks before randomization
- Recent oral corticosteroid treatment or hospitalization for COPD exacerbation within 4 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
3
Amicis Research Center
Valencia, California, United States, 91355
Actively Recruiting
4
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
5
Synergy Healthcare
Bradenton, Florida, United States, 34209
Withdrawn
6
Columbus Clinical Services, LLC
Miami, Florida, United States, 33125
Actively Recruiting
7
Pharmax Research of South Florida, Inc.
Miami, Florida, United States, 33175
Actively Recruiting
8
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States, 33407
Actively Recruiting
9
Primeway Clinical Research Group
Fayetteville, Georgia, United States, 30214
Actively Recruiting
10
Pivotal Research Solutions
Stonecrest, Georgia, United States, 30038
Actively Recruiting
11
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
12
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
13
Ochsner Medical Complex - The Grove
Baton Rouge, Louisiana, United States, 70836
Actively Recruiting
14
Stony Brook University Hospital
Stony Brook, New York, United States, 11733
Actively Recruiting
15
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, United States, 27705
Actively Recruiting
16
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
17
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
18
Inquest Clinical Research
Baytown, Texas, United States, 77521
Actively Recruiting
19
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States, 75020
Actively Recruiting
20
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States, 78503
Actively Recruiting
21
Vermont Lung Center
Colchester, Vermont, United States, 05446
Not Yet Recruiting
22
Carilion Medical Center / Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Actively Recruiting
23
Hospital Italiano de Buenos Aires
CABA, Buenos Aires, Argentina, C1199
Actively Recruiting
24
CEMER - Centro Medico de Enfermedades Respiratorias
Florida, Buenos Aires, Argentina, B1602
Actively Recruiting
25
Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, Argentina, 7600
Actively Recruiting
26
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina, B7600FYK
Actively Recruiting
27
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina, 1629
Actively Recruiting
28
Centro Medico Ipam S.A
Rosario, Santa Fe Province, Argentina, S2000
Not Yet Recruiting
29
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
30
Centro de Diagnostivo y Rehabilitación S.A. - CEDIR
Santa Fe, Argentina, S3000
Actively Recruiting
31
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
32
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
33
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
34
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
35
Institute for Respiratory Health
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
36
JSC "National Center for Lung Health"
Tbilisi, Georgia, 0101
Actively Recruiting
37
LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia, 0112
Actively Recruiting
38
Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, Georgia, 0159
Actively Recruiting
39
Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, Georgia, 0159
Actively Recruiting
40
Caucasus Medical Center
Tbilisi, Georgia, 0159
Actively Recruiting
41
LLC Diacor
Tbilisi, Georgia, 0159
Actively Recruiting
42
Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, Serbia, 11040
Actively Recruiting
43
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Serbia, 21204
Actively Recruiting
44
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
45
Institute for Pulmonary Diseases and Tuberculosis Nis
Niš, Serbia, 18108
Actively Recruiting
46
Health Center Uzice
Užice, Serbia, 31000
Actively Recruiting
47
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, United Kingdom, M23 9QZ
Actively Recruiting
48
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
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
51
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, United Kingdom, M6 8HD
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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