Status:
RECRUITING
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Lead Sponsor:
Connect Biopharm LLC
Conditions:
COPD Acute Exacerbation
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06940154
Start Date
August 12 2025
End Date
May 1 2026
Last Update
January 9 2026
Active Locations (32)
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1
University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, United States, 35233
2
Amicis Research Center
Valencia, California, United States, 91355
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Synergy Healthcare
Bradenton, Florida, United States, 34209