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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD) (NCT06940154) is a Phase 2 interventional studying COPD Acute Exacerbation, sponsored by Connect Biopharm LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against COPD Acute Exacerbation and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused COPD Acute Exacerbation subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 weakened immune system 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 systemic corticosteroids (ie, oral or by injection) 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.

Treatments Being Tested

COMBINATION_PRODUCT

Rademikibart in prefilled syringe

Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

DRUG

Matching placebo in prefilled syringe

Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, United States
Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, United States
Amicis Research Center
Valencia, California, United States
National Jewish Health
Denver, Colorado, United States
Synergy Healthcare
Bradenton, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
Pharmax Research of South Florida, Inc.
Miami, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Primeway Clinical Research Group
Fayetteville, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Medical Complex - The Grove
Baton Rouge, Louisiana, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Inquest Clinical Research
Baytown, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06940154), the sponsor (Connect Biopharm LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06940154 clinical trial studying?

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06940154?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06940154?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06940154. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06940154. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.