COPD Acute ExacerbationPhase 2NCT06940154
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
A Phase 2 study testing Rademikibart in prefilled syringe in people with COPD Acute Exacerbation, run by Connect Biopharm LLC at 52 sites in 6 countries.
Trial summary
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD Acute Exacerbation
- What is being tested?
- Rademikibart in prefilled syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 52 sitesin 6 countries
- Study dates
- 12 Aug 2025to 26 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
52 sites in 6 countries.
52 sites in 6 countries
United States21 sites
Ochsner Medical Complex - The Grove
Baton Rouge, Louisiana, 70836
Inquest Clinical Research
Baytown, Texas, 77521
University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, 35233
Vermont Lung Center
Colchester, Vermont, 05446
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
National Jewish Health
Denver, Colorado, 80206
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, 27705
Primeway Clinical Research Group
Fayetteville, Georgia, 30214
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503
Columbus Clinical Services, LLC
Miami, Florida, 33125
Pharmax Research of South Florida, Inc.
Miami, Florida, 33175
Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, 94304
Carilion Medical Center / Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Pivotal Research Solutions
Stonecrest, Georgia, 30038
Stony Brook University Hospital
Stony Brook, New York, 11733
Amicis Research Center
Valencia, California, 91355
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
Argentina8 sites
Hospital Italiano de Buenos Aires
CABA, Buenos Aires, C1199
CEMER - Centro Medico de Enfermedades Respiratorias
Florida, Buenos Aires, B1602
Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, 7600
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK
Hospital Universitario Austral
Pilar, Buenos Aires, 1629
Centro Medico Ipam S.A
Rosario, Santa Fe Province, S2000
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, 4000
Centro de Diagnostivo y Rehabilitación S.A. - CEDIR
Santa Fe, S3000
Australia7 sites
Bendigo Health
Bendigo, Victoria, 3550
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Campbelltown Hospital
Campbelltown, New South Wales, 2560
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Institute for Respiratory Health
Nedlands, Western Australia, 6009
Westmead Hospital
Westmead, New South Wales, 2145
Georgia6 sites
JSC "National Center for Lung Health"
Tbilisi, 0101
LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, 0159
Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, 0159
Caucasus Medical Center
Tbilisi, 0159
LLC Diacor
Tbilisi, 0159
Serbia5 sites
Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, 11040
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204
University Clinical Center Kragujevac
Kragujevac, 34000
Institute for Pulmonary Diseases and Tuberculosis Nis
Niš, 18108
Health Center Uzice
Užice, 31000
United Kingdom5 sites
Queen Elizabeth hospital Birmingham
Birmingham, B15 2GW
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, B9 5SS
Guy's and St Thomas NHS Foundation Trust
London, SE1 7EH
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, M6 8HD
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, M23 9QZ
About this study
Official title: 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
Read the 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).
- Conditions
- COPD Acute Exacerbation
- Being tested
- Rademikibart in prefilled syringe, Matching placebo in prefilled syringe
- Keywords
- COPD, chronic obstructive pulmonary disease, rademikibart, Connect Biopharma, CBP-201, COPD exacerbation, type 2 inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rademikibart in prefilled syringeCombination product
Also called CBP-201
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Matching placebo in prefilled syringeDrug
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Rademikibart | Experimental | Not described Receives: Combination Product: Rademikibart in prefilled syringe |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo in prefilled syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate
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.
Measured: 28 days
Secondary outcomes (8)
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Measured: Week 1
Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
Measured: 28 days
Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
Measured: 28 days
Mean CFB in EXACT-PRO score
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.
Measured: Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1 at Day 3 and Week 4
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Day 3, Week 1, and Week 4
Measured: Day 3, Week 1, and Week 4
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
Measured: 56 days
Incidence of unanticipated adverse device effects (UADEs)
Measured: 56 days
Incidence of injection site reactions
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start12 Aug 2025
- Primary completion30 Jul 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Acute ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connect Biopharm LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940154
- Sponsor's protocol ID
- CBP-201-207
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06940154
- Acronym / sponsor ID
- CBP-201-207
- Conditions
- COPD Acute Exacerbation
- Keywords
- COPD, chronic obstructive pulmonary disease, rademikibart, Connect Biopharma, CBP-201, COPD exacerbation, type 2 inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Connect Biopharm LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rademikibart | Experimental | Combination Product: Rademikibart in prefilled syringe |
| Placebo | Placebo comparator | Drug: Matching placebo in prefilled syringe |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rademikibart in prefilled syringeAlso: CBP-201Participants receive 600 mg (4mL) of rademikibart administered subcutaneously. | Combination product | Rademikibart |
| Matching placebo in prefilled syringeParticipants receive 4mL of placebo matched to rademikibart administered subcutaneously. | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Time frame: Week 1
Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
Time frame: 28 days
Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
Time frame: 28 days
Mean CFB in EXACT-PRO score
Time frame: 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
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
Incidence of unanticipated adverse device effects (UADEs)
Time frame: 56 days
Incidence of injection site reactions
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rademikibart in prefilled syringe in people with COPD Acute Exacerbation, run by Connect Biopharm LLC at 52 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Argentina, Australia, Georgia, Serbia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.