Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

July 10, 2026 updated by: Connect Biopharm LLC

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Santa Fe, Argentina, S3000
        • Centro de Diagnostivo y Rehabilitación S.A. - CEDIR
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1199
        • Hospital Italiano de Buenos Aires
      • Florida, Buenos Aires, Argentina, B1602
        • CEMER - Centro Medico de Enfermedades Respiratorias
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Centro de Investigaciones Medicas Mar del Plata
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto Ave Pulmo-Fundacion Enfisema
      • Pilar, Buenos Aires, Argentina, 1629
        • Hospital Universitario Austral
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000
        • Centro Medico Ipam S.A
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigaciones en Patologías Respiratorias SRL
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Institute for Respiratory Health
  • Georgia
      • Tbilisi, Georgia, 0159
        • Acad. G. Chapidze Emergency Cardiology Center
      • Tbilisi, Georgia, 0159
        • LLC Diacor
      • Tbilisi, Georgia, 0101
        • JSC "National Center for Lung Health"
      • Tbilisi, Georgia, 0112
        • LLC "Israel-Georgian Medical Research Clinic Healthycore"
      • Tbilisi, Georgia, 0159
        • Acad. Chapidze Emergency Cardiology Center LLC
      • Tbilisi, Georgia, 0159
        • Caucasus Medical Center
  • Serbia
      • Belgrade, Serbia, 11040
        • Clinical Hospital Center "Dragisa Misovic - Dedinje"
      • Kamenitz, Serbia, 21204
        • Institute for Pulmonary Diseases of Vojvodina
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
      • Niš, Serbia, 18108
        • Institute for Pulmonary Diseases and Tuberculosis Nis
      • Užice, Serbia, 31000
        • Health Center Uzice
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital Birmingham
      • Birmingham, United Kingdom, B9 5SS
        • University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas NHS Foundation Trust
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
    • Greater Manchester
      • Wythenshawe, Greater Manchester, United Kingdom, M23 9QZ
        • Medicines Evaluation Unit Ltd.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Lung Health Center
    • California
      • Palo Alto, California, United States, 94304
        • Leland Stanford Junior University, Stanford Hospital
      • Valencia, California, United States, 91355
        • Amicis Research Center
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Miami, Florida, United States, 33175
        • Pharmax Research of South Florida, Inc.
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services, LLC
      • West Palm Beach, Florida, United States, 33407
        • Health Synergy Clinical Research, LLC
    • Georgia
      • Fayetteville, Georgia, United States, 30214
        • Primeway Clinical Research Group
      • Stonecrest, Georgia, United States, 30038
        • Pivotal Research Solutions
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Ochsner Medical Complex - The Grove
    • New York
      • Stony Brook, New York, United States, 11733
        • Stony Brook University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Asthma, Allergy, and Airway Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Denison, Texas, United States, 75020
        • Premier Pulmonary Critical Care and Sleep Medicine
      • McAllen, Texas, United States, 78503
        • DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
    • Vermont
      • Colchester, Vermont, United States, 05446
        • Vermont Lung Center
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Medical Center / Carilion Roanoke Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Matching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Experimental: Rademikibart
Combination product: Rademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Other Names:
  • CBP-201

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment failure rate
Time Frame: 28 days
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
Time Frame: 28 days
28 days
Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
Time Frame: 28 days
28 days
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
Time Frame: 56 days
56 days
Incidence of unanticipated adverse device effects (UADEs)
Time Frame: 56 days
56 days
Incidence of injection site reactions
Time Frame: 56 days
56 days
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Time Frame: Week 1
Week 1
Mean CFB in EXACT-PRO score
Time Frame: Week 1, Week 2, and Week 4
Mean CFB in clinical respiratory symptoms of COPD using the E-RS: COPD (Evaluating Respiratory Symptoms in COPD) comprised in the EXACT-PRO through Week 1, Week 2, and Week 4. The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome (EXACT-PRO) is a PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in patients with COPD.
Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1 at Day 3 and Week 4
Time Frame: Day 3, Week 1, and Week 4
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Day 3, Week 1, and Week 4
Day 3, Week 1, and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Connect Biopharm LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBP-201-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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