Asthma AcutePhase 2NCT06940141
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
A Phase 2 study testing Rademikibart in prefilled syringe in people with Asthma Acute, run by Connect Biopharm LLC at 58 sites in 6 countries.
Trial summary
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma Acute
- 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
- 160 participants
- Where
- 58 sitesin 6 countries
- Study dates
- 8 Aug 2025to 10 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician-diagnosed asthma with duration of ≥12 months.
- Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
- Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
- For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
- Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
- Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
- Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
- FEV1 ≥30% predicted.
Who cannot join
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- Current or former smoker, has a smoking history including: If <30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
- COPD and other clinically significant pulmonary disease other than asthma.
- Known or suspected history of immunosuppression.
- History of known immunodeficiency disorder or hepatitis B or C.
Show all 17Show fewer
- 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 with curative therapy or other malignancies treated with apparent success with curative therapy.
- Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization.
- Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate).
- Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
- Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
- Participants that have been recently treated with bronchial thermoplasty.
- Recent treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of asthma.
- Recent receipt of any investigational nonbiologic drug.
- A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population.
- 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
58 sites in 6 countries.
58 sites in 6 countries
United States21 sites
Inquest Clinical Research
Baytown, Texas, 77521
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
Primeway Clinical Research Group
Fayetteville, Georgia, 30214
University of Iowa
Iowa City, Iowa, 52242
Nemours Children's Health
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503
Pharmax Research of South Florida, Inc.
Miami, Florida, 33175
Columbus Clinical Services, LLC
Miami, Florida, 33215
Nemours Children's Health, Lake Nona
Orlando, Florida, 32827
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301
Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, 94304
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Washington University School of Medicine
St Louis, Missouri, 63110
Pivotal Research Solutions
Stonecrest, Georgia, 30038
Amicis Research Center
Valencia, California, 91355
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
Nemours Children's Hospital - DE
Wilmington, Delaware, 19803
Argentina11 sites
STAT Research
Caba, Buenos Aires, C1023
Hospital Italiano de Buenos Aires
Caba, Buenos Aires, C1199
Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
Caba, Buenos Aires, C1425BEN
Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, 7600
INSARES
Mendoza, 5500CCG
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT
Centro respiratorio Infantil
Rosario, Santa Fe Province, 2000
INECO Neurociencias Oroño
Rosario, Santa Fe Province, S2000
CEMER - Centro Medico de Enfermedades Respiratorias
San Juan Bautista, Buenos Aires, B1602
Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, 4000
Centro de Diagnostico y Rehabilitación S.A. -CEDIR
Santa Fe, S3000
United Kingdom8 sites
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham
Birmingham, B15 2GW
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, B9 5SS
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD96RJ
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Kings College Hospital NHS Foundation
London, SE5 9RS
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, Greater Manchester, M6 8HD
Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, M23 9QZ
Australia6 sites
Bendigo Health
Bendigo, Victoria, 3550
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
St George Hospital, South Eastern Sydney Local Health District
Kogarah, New South Wales, 2217
Queensland Children's Hospital
South Brisbane, Queensland, 4101
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
Caucasus Medical Center
Tbilisi, 0159
LLC Diacor
Tbilisi, 0159
Raymann, LLC
Tbilisi, 0186
Serbia6 sites
Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, 11040
Clinical Hospital Center Zemun
Belgrade, 11080
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
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 Adult and Adolescent Participants With Asthma and Type 2 Inflammation
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma 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 asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.
- Conditions
- Asthma Acute
- Being tested
- Rademikibart in prefilled syringe, Matching placebo in prefilled syringe
- Keywords
- Acute exacerbation, Asthma, Asthma exacerbation, CBP-201, Rademikibart, Connect Biopharma
- Medical subject headings
- Asthma
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 within 28 days after randomization
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
Measured: 28 days
Secondary outcomes (9)
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 asthma exacerbations in the 28 days after randomization
Measured: 28 days
Time to the first new asthma exacerbation in the 28 days after randomization
Measured: 28 days
Mean CFB in morning/evening asthma symptom score
Measured: Week 1, Week 2, and Week 4
Mean CFB in nocturnal awakenings (e-diary)
Measured: Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1
Measured: Day 3 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 start8 Aug 2025
- Primary completion17 Jul 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies 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
- 160 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
- NCT06940141
- Sponsor's protocol ID
- CBP-201-206
- 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
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 Adult and Adolescent Participants With Asthma and Type 2 Inflammation
- ClinicalTrials.gov ID
- NCT06940141
- Acronym / sponsor ID
- CBP-201-206
- Conditions
- Asthma Acute
- Keywords
- Acute exacerbation, Asthma, Asthma exacerbation, CBP-201, Rademikibart, Connect Biopharma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Connect Biopharm LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 10 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, randomized, multicenter study in adult and adolescent participants with asthma 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 asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.
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
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Physician-diagnosed asthma with duration of ≥12 months.
- Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
- Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
- For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
- Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
Key exclusion criteria (17 listed)
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- Current or former smoker, has a smoking history including: If <30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
- COPD and other clinically significant pulmonary disease other than asthma.
- Known or suspected history of immunosuppression.
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 within 28 days after randomization
Time frame: 28 days
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
9 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 asthma exacerbations in the 28 days after randomization
Time frame: 28 days
Time to the first new asthma exacerbation in the 28 days after randomization
Time frame: 28 days
Mean CFB in morning/evening asthma symptom score
Time frame: Week 1, Week 2, and Week 4
Mean CFB in nocturnal awakenings (e-diary)
Time frame: Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1
Time frame: Day 3 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.
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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.
58 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 Asthma Acute, run by Connect Biopharm LLC at 58 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 8 inclusion and 17 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 58 sites in United States, Argentina, United Kingdom, Australia, Georgia 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 within 28 days after randomization (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.