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Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
NCT06940154 · Connect Biopharm LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).
Eligibility criteria
Inclusion Criteria:
* Physician-diagnosed COPD with duration of ≥12 months.
* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
* Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
* Current or former smoker with a history of smoking of ≥10 pack-years.
* Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
* Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
* Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.
Exclusion Criteria:
* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
* Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
* Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
* Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
* Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \<6 months from Screening Visit.
* 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.
* Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for \>15 hours a day.
* Participants on long-term macrolide.
* Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening.
* A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
* Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
* Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
* Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
* Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
* Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.
The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study design
Enrollment target: 160 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-08-12
Estimated completion: 2026-05
Last updated: 2026-03-31
Interventions
Combination Product: Rademikibart in prefilled syringeDrug: Matching placebo in prefilled syringe
Primary outcomes
- • Treatment failure rate (28 days)
Sponsor
Connect Biopharm LLC · industry
Contacts & investigators
ContactRadha Adivikolanu · contact · clinical207@connectpharm.com · 213-522-7990
All locations (46)
University of Alabama at Birmingham Lung Health CenterRecruiting
Birmingham, Alabama, United States
Amicis Research CenterRecruiting
Valencia, California, United States
National Jewish HealthRecruiting
Denver, Colorado, United States
Synergy HealthcareWithdrawn
Bradenton, Florida, United States
Columbus Clinical Services, LLCRecruiting
Miami, Florida, United States
Pharmax Research of South Florida, Inc.Recruiting
Miami, Florida, United States
Health Synergy Clinical Research, LLCRecruiting
West Palm Beach, Florida, United States
Primeway Clinical Research GroupRecruiting
Fayetteville, Georgia, United States
Pivotal Research SolutionsRecruiting
Stonecrest, Georgia, United States
University of IowaRecruiting
Iowa City, Iowa, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Duke Asthma, Allergy, and Airway CenterRecruiting
Durham, North Carolina, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Clinical Research of Rock HillRecruiting
Rock Hill, South Carolina, United States
Inquest Clinical ResearchRecruiting
Baytown, Texas, United States
Premier Pulmonary Critical Care and Sleep MedicineRecruiting
Denison, Texas, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical TrialsRecruiting
McAllen, Texas, United States
Carilion Medical Center / Carilion Roanoke Memorial HospitalRecruiting
Roanoke, Virginia, United States
CEMER - Centro Medico de Enfermedades RespiratoriasRecruiting
Florida, Buenos Aires, Argentina
Instituto Ave Pulmo-Fundacion EnfisemaRecruiting
Mar del Plata, Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del PlataRecruiting
Mar del Plata, Buenos Aires, Argentina
Hospital Universitario AustralRecruiting
Pilar, Buenos Aires, Argentina
Centro Medico Ipam S.ANot Yet Recruiting
Rosario, Santa Fe Province, Argentina
Investigaciones en Patologias Respiratorias SRLRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Diagnostivo y Rehabilitación S.A. - CEDIRRecruiting
Santa Fe, Argentina
The Canberra HospitalRecruiting
Garran, Australian Capital Territory, Australia
St. Vincent's Hospital SydneyRecruiting
Darlinghurst, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Sunshine Coast University HospitalRecruiting
Birtinya, Queensland, Australia
Institute for Respiratory HealthRecruiting
Nedlands, Western Australia, Australia
JSC "National Center for Lung Health"Recruiting
Tbilisi, Georgia
LLC "Israel-Georgian Medical Research Clinic Healthycore"Recruiting
Tbilisi, Georgia
Acad. Chapidze Emergency Cardiology Center LLCRecruiting
Tbilisi, Georgia
Acad. G. Chapidze Emergency Cardiology CenterRecruiting
Tbilisi, Georgia
Caucasus Medical CenterRecruiting
Tbilisi, Georgia
LLC DiacorRecruiting
Tbilisi, Georgia
Clinical Hospital Center "Dragisa Misovic - Dedinje"Recruiting
Belgrade, Serbia
Institute for Pulmonary Diseases of VojvodinaRecruiting
Kamenitz, Serbia
University Clinical Center KragujevacRecruiting
Kragujevac, Serbia
Institute for Pulmonary Diseases and Tuberculosis NisRecruiting
Niš, Serbia
Health Center UziceRecruiting
Užice, Serbia
Medicines Evaluation Unit Ltd.Recruiting
Wythenshawe, Greater Manchester, United Kingdom
Queen Elizabeth hospital BirminghamRecruiting
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands HospitalRecruiting
Birmingham, United Kingdom
Guy's and St Thomas NHS Foundation TrustRecruiting
London, United Kingdom
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research FacilityRecruiting
Salford, United Kingdom