Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
ConditionCOPD Acute Exacerbation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorConnect Biopharm LLC
About this trial
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Rademikibart in prefilled syringe
- Matching placebo in prefilled syringe
Treatment groups
160 Participants
are divided into 2 treatment groupsLocations
53Argentina
Hospital Italiano de Buenos AiresC1199, CABABuenos Aires, Argentina
CEMER - Centro Medico de Enfermedades RespiratoriasB1602, FloridaBuenos Aires, Argentina
Centro de Investigaciones Médicas Mar del PlataB7600FYK, Mar del PlataBuenos Aires, Argentina
Instituto Ave Pulmo-Fundacion Enfisema7600, Mar del PlataBuenos Aires, Argentina
Sponsors and collaborators
Connect Biopharm LLC
Lead sponsor
Source ClinicalTrials.gov