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

NCT06940141 · Connect Biopharm LLC
In plain English

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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
About this study
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.
Eligibility criteria
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 OCS 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 design
Enrollment target: 160 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2025-08-08
Estimated completion: 2026-05
Last updated: 2026-03-31
Interventions
Combination Product: Rademikibart in prefilled syringeDrug: Matching placebo in prefilled syringe
Primary outcomes
  • Treatment failure rate within 28 days after randomization (28 days)
Sponsor
Connect Biopharm LLC · industry
Contacts & investigators
ContactRadha Adivikolanu · contact · clinical206@connectpharm.com · 213-522-7990
All locations (49)
Amicis Research CenterRecruiting
Valencia, California, United States
Synergy HealthcareWithdrawn
Bradenton, Florida, United States
Pharmax Research of South Florida, Inc.Recruiting
Miami, Florida, United States
Columbus Clinical Services, LLCRecruiting
Miami, Florida, United States
Health Synergy Clinical Research, LLCRecruiting
West Palm Beach, Florida, United States
Primeway Clinical Research GroupRecruiting
Fayetteville, Georgia, United States
Pivotal Research SolutionsRecruiting
Stonecrest, Georgia, United States
University of IowaRecruiting
Iowa City, Iowa, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Allergy & Asthma Specialists, P.S.C.Recruiting
Owensboro, Kentucky, United States
Chesapeake Clinical Research, Inc.Recruiting
White Marsh, Maryland, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Clinical Research of Rock HillRecruiting
Rock Hill, South Carolina, United States
Inquest Clinical ResearchRecruiting
Baytown, Texas, United States
Premier Pulmonary Critical Care and Sleep MedicineRecruiting
Denison, Texas, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical TrialsRecruiting
McAllen, Texas, United States
STAT ResearchNot Yet Recruiting
Caba, Buenos Aires, Argentina
Hospital Italiano de Buenos AiresNot Yet Recruiting
Caba, Buenos Aires, Argentina
Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)Recruiting
Caba, Buenos Aires, Argentina
Instituto Ave Pulmo-Fundacion EnfisemaRecruiting
Mar del Plata, Buenos Aires, Argentina
Centro respiratorio InfantilNot Yet Recruiting
Rosario, Santa Fe Province, Argentina
INECO Neurociencias OroñoRecruiting
Rosario, Santa Fe Province, Argentina
Investigaciones en Patologias Respiratorias SRLRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
INSARESNot Yet Recruiting
Mendoza, Argentina
The Canberra HospitalRecruiting
Garran, Australian Capital Territory, Australia
St. Vincent's Hospital SydneyRecruiting
Darlinghurst, New South Wales, Australia
St George Hospital, South Eastern Sydney Local Health DistrictRecruiting
Kogarah, New South Wales, Australia
Queensland Children's HospitalRecruiting
South Brisbane, Queensland, Australia
Bendigo HealthRecruiting
Bendigo, Victoria, Australia
JSC "National Center for Lung Health"Recruiting
Tbilisi, Georgia
LLC "Israel-Georgian Medical Research Clinic Healthycore"Recruiting
Tbilisi, Georgia
Acad. Chapidze Emergency Cardiology Center LLCRecruiting
Tbilisi, Georgia
Caucasus Medical CenterRecruiting
Tbilisi, Georgia
LLC DiacorRecruiting
Tbilisi, Georgia
Raymann, LLCRecruiting
Tbilisi, Georgia
Clinical Hospital Center "Dragisa Misovic - Dedinje"Recruiting
Belgrade, Serbia
Institute for Pulmonary Diseases of VojvodinaRecruiting
Kamenitz, Serbia
University Clinical Center KragujevacRecruiting
Kragujevac, Serbia
Institute for Pulmonary Diseases and Tuberculosis NisRecruiting
Niš, Serbia
Health Center UziceRecruiting
Užice, Serbia
Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research FacilityRecruiting
Salford, Greater Manchester, United Kingdom
Medicines Evaluation Unit Ltd.Recruiting
Wythenshawe, Greater Manchester, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation TrustRecruiting
Norwich, Norfolk, United Kingdom
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital BirminghamRecruiting
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands HospitalRecruiting
Birmingham, United Kingdom
Bradford Teaching Hospitals NHS Foundation TrustRecruiting
Bradford, United Kingdom
Guy's and St Thomas' NHS Foundation TrustRecruiting
London, United Kingdom
Kings College Hospital NHS FoundationRecruiting
London, United Kingdom
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma) · TrialPath