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NCT07705737
Rademikibart IV for Acute Asthma and COPD Exacerbation
Conditions: Asthma Acute, COPD Exacerbation Acute
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Connect Biopharm LLC
Location: Columbus Clinical Services, LLC Miami Florida
Summary
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
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 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 \
Source: ClinicalTrials.gov (NCT07705737). StuddyBuddy aggregates publicly available trial information.