Last updated 14 days ago
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
160 patients around the world
Available in Argentina, United States
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).
Connect Biopharm LLC
1Research sites
160Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto de Investigaciones en Patologías Respiratorias SRL - Tucumán
SponsorConnect Biopharm LLC
Study typeInterventional
Conditions
Copd
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06940154
