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

June 18, 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 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • 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 Locations

  • Argentina
      • Mendoza, Argentina, 5500CCG
        • INSARES
      • Santa Fe, Argentina, S3000
        • Centro de Diagnostico y Rehabilitación S.A. -CEDIR
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1023
        • Stat Research
      • Caba, Buenos Aires, Argentina, C1199
        • Hospital Italiano de Buenos Aires
      • Caba, Buenos Aires, Argentina, C1425BEN
        • Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto Ave Pulmo-Fundacion Enfisema
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Hospital Universitario Austral
      • San Juan Bautista, Buenos Aires, Argentina, B1602
        • CEMER - Centro Medico de Enfermedades Respiratorias
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Centro respiratorio Infantil
      • Rosario, Santa Fe Province, Argentina, S2000
        • INECO Neurociencias Oroño
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigaciones en Patologias 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
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital, South Eastern Sydney Local Health District
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Queensland Children's Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Health
  • Georgia
      • 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
      • Tbilisi, Georgia, 0186
        • Raymann, LLC
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Zemun
      • 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
        • University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham
      • Birmingham, United Kingdom, B9 5SS
        • University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
      • Bradford, United Kingdom, BD96RJ
        • Bradford Teaching Hospitals NHS Foundation Trust
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
      • Wythenshawe, Greater Manchester, United Kingdom, M23 9QZ
        • Medicines Evaluation Unit Ltd.
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital NHS Foundation Trust
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Leland Stanford Junior University, Stanford Hospital
      • Valencia, California, United States, 91355
        • Amicis Research Center
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Hospital - DE
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Health
      • Miami, Florida, United States, 33175
        • Pharmax Research of South Florida, Inc.
      • Miami, Florida, United States, 33215
        • Columbus Clinical Services, LLC
      • Orlando, Florida, United States, 32827
        • Nemours Children's Health, Lake Nona
      • 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
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Allergy & Asthma Specialists, P.S.C.
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Chesapeake Clinical Research, Inc.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • 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

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Rate of new asthma exacerbations in the 28 days after randomization
Time Frame: 28 days
28 days
Time to the first new asthma exacerbation in the 28 days after randomization
Time Frame: 28 days
28 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 morning/evening asthma symptom score
Time Frame: Week 1, Week 2, and Week 4
Week 1, Week 2, and Week 4
Mean CFB in nocturnal awakenings (e-diary)
Time Frame: Week 1, Week 2, and Week 4
Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1
Time Frame: Day 3 and Week 4
Day 3 and Week 4

Collaborators and Investigators

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

Sponsor

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)

August 8, 2025

Primary Completion (Estimated)

July 13, 2026

Study Completion (Estimated)

August 10, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBP-201-206

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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