New shot could tame asthma Flare-Ups
NCT ID NCT06940141
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times
Summary
This Phase 2 trial tests whether adding rademikibart (a shot) to standard care can help adults and teens with asthma and type 2 inflammation avoid hospital visits or needing more steroids during an attack. About 160 participants will receive either the drug or a placebo. The main goal is to see if the drug reduces treatment failure within 28 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rademikibart (also known as CBP-201), given as a shot under the skin
- What this could lead to
- If it works, this could provide a new add-on treatment to reduce hospital visits and need for extra steroids during asthma attacks.
- What could go wrong
- This is an early Phase 2 trial with only 160 people, so results may not apply to everyone. The drug may not lower treatment failure rates or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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160 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Acad. Chapidze Emergency Cardiology Center LLC
Tbilisi, 0159, Georgia
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Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301, United States
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Amicis Research Center
Valencia, California, 91355, United States
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Bendigo Health
Bendigo, Victoria, 3550, Australia
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Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD96RJ, United Kingdom
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CEMER - Centro Medico de Enfermedades Respiratorias
San Juan Bautista, Buenos Aires, B1602, Argentina
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Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
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Caucasus Medical Center
Tbilisi, 0159, Georgia
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Centro de Diagnostico y Rehabilitación S.A. -CEDIR
Santa Fe, S3000, Argentina
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Centro respiratorio Infantil
Rosario, Santa Fe Province, 2000, Argentina
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Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162, United States
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Clinical Hospital Center "Dragisa Misovic - Dedinje"
Belgrade, 11040, Serbia
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Clinical Hospital Center Zemun
Belgrade, 11080, Serbia
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Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
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Columbus Clinical Services, LLC
Miami, Florida, 33215, United States
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DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503, United States
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Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
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Health Center Uzice
Užice, 31000, Serbia
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Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407, United States
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Hospital Italiano de Buenos Aires
Caba, Buenos Aires, C1199, Argentina
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Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
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INECO Neurociencias Oroño
Rosario, Santa Fe Province, S2000, Argentina
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INSARES
Mendoza, 5500CCG, Argentina
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Inquest Clinical Research
Baytown, Texas, 77521, United States
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Institute for Pulmonary Diseases and Tuberculosis Nis
Niš, 18108, Serbia
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Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204, Serbia
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Instituto Ave Pulmo-Fundacion Enfisema
Mar del Plata, Buenos Aires, 7600, Argentina
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Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
Caba, Buenos Aires, C1425BEN, Argentina
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Investigaciones en Patologias Respiratorias SRL
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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JSC "National Center for Lung Health"
Tbilisi, 0101, Georgia
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Kings College Hospital NHS Foundation
London, SE5 9RS, United Kingdom
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LLC "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112, Georgia
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LLC Diacor
Tbilisi, 0159, Georgia
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Leland Stanford Junior University, Stanford Hospital
Palo Alto, California, 94304, United States
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Medicines Evaluation Unit Ltd.
Wythenshawe, Greater Manchester, M23 9QZ, United Kingdom
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Nemours Children's Health
Jacksonville, Florida, 32207, United States
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Nemours Children's Health, Lake Nona
Orlando, Florida, 32827, United States
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Nemours Children's Hospital - DE
Wilmington, Delaware, 19803, United States
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Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
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Pharmax Research of South Florida, Inc.
Miami, Florida, 33175, United States
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Pivotal Research Solutions
Stonecrest, Georgia, 30038, United States
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Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020, United States
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Primeway Clinical Research Group
Fayetteville, Georgia, 30214, United States
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Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
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Raymann, LLC
Tbilisi, 0186, Georgia
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STAT Research
Caba, Buenos Aires, C1023, Argentina
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Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
Salford, Greater Manchester, M6 8HD, United Kingdom
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St George Hospital, South Eastern Sydney Local Health District
Kogarah, New South Wales, 2217, Australia
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St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
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The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
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The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
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University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
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University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham
Birmingham, B15 2GW, United Kingdom
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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Vermont Lung Center
Colchester, Vermont, 05446, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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