Rademikibart IV for Acute Asthma and COPD Exacerbation
Rademikibart IV for Acute Asthma and COPD Exacerbation
Recruiting
Phase 2Interventional Study
Asthma AcuteCOPD Exacerbation Acute
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Connect Biopharm LLC · Industry
Who this trial is looking for
This trial is looking for adults with asthma or COPD who are currently experiencing a serious flare-up. Participants will receive an intravenous treatment called rademikibart in addition to their usual care.
Are You a Good Fit for This Trial?
Must be takingICS
You may be able to join if
I weigh at least 40 kg for asthma or 45 kg for COPD.
I have been diagnosed with asthma or COPD by a doctor.
I have had at least one exacerbation requiring corticosteroids.
I am currently having an acute exacerbation and need urgent treatment.
I have a recent eosinophil count of at least 300 cells/µL.
You may not be able to join if
I regularly use immunosuppressive medications.
I have unstable heart disease or uncontrolled high blood pressure.
I smoke or have a significant smoking history.
I have any significant lung disease other than asthma or COPD.
I have a history of immunodeficiency or hepatitis B or C.
I have had recent cancer (except for certain skin types).
I am pregnant, breastfeeding, or lactating.
I have had recent vaccinations or treatments that affect my immune system.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation
Trial Locations
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Eligibility Criteria
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 exa…
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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