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Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Sponsor: Connect Biopharm LLC
Summary
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Official title: 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 Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-08-12
Completion Date
2026-05
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (46)
University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, United States
Amicis Research Center
Valencia, California, United States
National Jewish Health
Denver, Colorado, United States
Synergy Healthcare
Bradenton, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
Pharmax Research of South Florida, Inc.
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 Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, 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
Carilion Medical Center / Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
CEMER - Centro Medico de Enfermedades Respiratorias
Florida, Buenos Aires, Argentina
Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Centro Medico Ipam S.A
Rosario, Santa Fe Province, Argentina
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Diagnostivo y Rehabilitación S.A. - CEDIR
Santa Fe, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia
JSC "National Center for Lung Health"
Tbilisi, Georgia
LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia
Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, Georgia
Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, Georgia
Caucasus Medical Center
Tbilisi, Georgia
LLC Diacor
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
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, United Kingdom
Queen Elizabeth hospital Birmingham
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, United Kingdom