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RECRUITING

NCT06940141

PHASE2

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

Sponsor: Connect Biopharm LLC

View on ClinicalTrials.gov

Summary

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

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

Key Details

Gender

All

Age Range

12 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-08-08

Completion Date

2026-05

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Asthma Acute

Interventions

COMBINATION_PRODUCT

Rademikibart in prefilled syringe

Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

DRUG

Matching placebo in prefilled syringe

Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

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.

Locations (49)

Amicis Research Center

Valencia, California, United States

Synergy Healthcare

Bradenton, Florida, United States

Pharmax Research of South Florida, Inc.

Miami, Florida, United States

Columbus Clinical Services, LLC

Miami, Florida, United States

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, United States

Primeway Clinical Research Group

Fayetteville, Georgia, United States

Pivotal Research Solutions

Stonecrest, Georgia, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, United States

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Inquest Clinical Research

Baytown, Texas, United States

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, United States

DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials

McAllen, Texas, United States

STAT Research

Caba, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Caba, Buenos Aires, Argentina

Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)

Caba, Buenos Aires, Argentina

Instituto Ave Pulmo-Fundacion Enfisema

Mar del Plata, Buenos Aires, Argentina

Centro respiratorio Infantil

Rosario, Santa Fe Province, Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

Investigaciones en Patologias Respiratorias SRL

San Miguel de Tucumán, Tucumán Province, Argentina

INSARES

Mendoza, Argentina

The Canberra Hospital

Garran, Australian Capital Territory, Australia

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

St George Hospital, South Eastern Sydney Local Health District

Kogarah, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Bendigo Health

Bendigo, Victoria, Australia

JSC "National Center for Lung Health"

Tbilisi, Georgia

LLC "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

Acad. Chapidze Emergency Cardiology Center LLC

Tbilisi, Georgia

Caucasus Medical Center

Tbilisi, Georgia

LLC Diacor

Tbilisi, Georgia

Raymann, LLC

Tbilisi, Georgia

Clinical Hospital Center "Dragisa Misovic - Dedinje"

Belgrade, Serbia

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Institute for Pulmonary Diseases and Tuberculosis Nis

Niš, Serbia

Health Center Uzice

Užice, Serbia

Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility

Salford, Greater Manchester, United Kingdom

Medicines Evaluation Unit Ltd.

Wythenshawe, Greater Manchester, United Kingdom

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, Norfolk, United Kingdom

University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham

Birmingham, United Kingdom

University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital

Birmingham, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Kings College Hospital NHS Foundation

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)