Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Purpose
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Condition
- COPD Acute Exacerbation
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rademikibart |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Contact:
Radha Adivikolanu
Radha Adivikolanu
More Details
- Status
- Recruiting
- Sponsor
- Connect Biopharm LLC
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 setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).