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New shot could tame asthma Flare-Ups

NCT ID NCT06940141

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

160 people

The number who actually took part.

Started

Aug 2025

Finished

Aug 2026

Lead sponsor

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

12 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Acad. Chapidze Emergency Cardiology Center LLC

    Tbilisi, 0159, Georgia

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301, United States

  • Amicis Research Center

    Valencia, California, 91355, United States

  • Bendigo Health

    Bendigo, Victoria, 3550, Australia

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, BD96RJ, United Kingdom

  • CEMER - Centro Medico de Enfermedades Respiratorias

    San Juan Bautista, Buenos Aires, B1602, Argentina

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560, Australia

  • Caucasus Medical Center

    Tbilisi, 0159, Georgia

  • Centro de Diagnostico y Rehabilitación S.A. -CEDIR

    Santa Fe, S3000, Argentina

  • Centro respiratorio Infantil

    Rosario, Santa Fe Province, 2000, Argentina

  • Chesapeake Clinical Research, Inc.

    White Marsh, Maryland, 21162, United States

  • Clinical Hospital Center "Dragisa Misovic - Dedinje"

    Belgrade, 11040, Serbia

  • Clinical Hospital Center Zemun

    Belgrade, 11080, Serbia

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Columbus Clinical Services, LLC

    Miami, Florida, 33215, United States

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

    McAllen, Texas, 78503, United States

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • Health Center Uzice

    Užice, 31000, Serbia

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407, United States

  • Hospital Italiano de Buenos Aires

    Caba, Buenos Aires, C1199, Argentina

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT, Argentina

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, S2000, Argentina

  • INSARES

    Mendoza, 5500CCG, Argentina

  • Inquest Clinical Research

    Baytown, Texas, 77521, United States

  • Institute for Pulmonary Diseases and Tuberculosis Nis

    Niš, 18108, Serbia

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204, Serbia

  • Instituto Ave Pulmo-Fundacion Enfisema

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)

    Caba, Buenos Aires, C1425BEN, Argentina

  • Investigaciones en Patologias Respiratorias SRL

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • JSC "National Center for Lung Health"

    Tbilisi, 0101, Georgia

  • Kings College Hospital NHS Foundation

    London, SE5 9RS, United Kingdom

  • LLC "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112, Georgia

  • LLC Diacor

    Tbilisi, 0159, Georgia

  • Leland Stanford Junior University, Stanford Hospital

    Palo Alto, California, 94304, United States

  • Medicines Evaluation Unit Ltd.

    Wythenshawe, Greater Manchester, M23 9QZ, United Kingdom

  • Nemours Children's Health

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Health, Lake Nona

    Orlando, Florida, 32827, United States

  • Nemours Children's Hospital - DE

    Wilmington, Delaware, 19803, United States

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Pharmax Research of South Florida, Inc.

    Miami, Florida, 33175, United States

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038, United States

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020, United States

  • Primeway Clinical Research Group

    Fayetteville, Georgia, 30214, United States

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Raymann, LLC

    Tbilisi, 0186, Georgia

  • STAT Research

    Caba, Buenos Aires, C1023, Argentina

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

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • St George Hospital, South Eastern Sydney Local Health District

    Kogarah, New South Wales, 2217, Australia

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • University Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

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

    Birmingham, B15 2GW, United Kingdom

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Vermont Lung Center

    Colchester, Vermont, 05446, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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