RecruitingPhase 2NCT06940154
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
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
Sponsor
Connect Biopharm LLC
Enrollment
160 participants
Start Date
Aug 12, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Eligibility
Min Age: 40 YearsMax Age: 80 Years
Inclusion Criteria7
- 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 Criteria18
- 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.
Interventions
COMBINATION_PRODUCTRademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
DRUGMatching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Locations(43)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06940154