Experimental drug aims to tame severe asthma and COPD attacks
NCT ID NCT07705737
First seen Jul 15, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This trial tests a single dose of rademikibart, given intravenously, as an add-on treatment for people hospitalized with an acute asthma or COPD flare-up who also have type 2 inflammation. The study includes 40 adults and measures how well the drug improves lung function and controls symptoms. The goal is to see if this approach can speed recovery and reduce the need for standard steroid treatments.
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 called CBP-201), given as a single 300 mg IV push
- What this could lead to
- If successful, this could provide a new option to quickly control severe asthma or COPD flare-ups and reduce the need for oral steroids.
- What could go wrong
- This is a small, early-phase trial with no placebo group, so results may not prove effectiveness. The drug may also cause 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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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- 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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18 to 85 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 - Asthma cohort * Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a. * Physician-diagnosed asthma * 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. * Participants in a stable condition, must have a 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 - Asthma cohort * Regular use of immunosuppressive medication. * Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. * Current or former smoker, with a smoking history of ≥5 pack-years if \<30 years old or ≥10 pack-years if ≥30 years old * 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 or other malignancies treated with apparent success with curative therapy. * Female participant who is pregnant, lactating or breast-feeding. * Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines. * 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 receipt of any investigational nonbiologic drug. * A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population. Inclusion Criteria - COPD cohort * Body weight of ≥45 kg and BMI ≤45 kg/m2 * Physician-diagnosed COPD * Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids. * Participants in a stable condition must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. * Current or former smoker with a history of smoking of ≥10 pack-years. * Current acute COPD exacerbation requiring an urgent healthcare visit for treatment. * Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation. * Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation. Exclusion Criteria - COPD cohort * Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, whichever is longer. * Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome. * Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results. * Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation. * Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \<6 months from Screening Visit. * 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. * Chronic treatment with long-term oxygen therapy or nocturnal oxygen therapy required for \>15 hours a day. * Participants on long-term macrolide. * Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening. * A recent chest X-ray or computed tomography scan reveals evidence of clinically significant abnormalities or pulmonary infection. * Female participant who is pregnant, lactating or breast-feeding. * Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer. * Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer. * Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial. 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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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Columbus Clinical Services, LLC
NOT_YET_RECRUITINGMiami, Florida, 33135, United States
Contact Email: •••••@•••••
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Pharmax Research of South Florida, Inc.
RECRUITINGMiami, Florida, 33175, United States
Contact Email: •••••@•••••
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