A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation
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
• 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.
• 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.