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
A phase 2, open-label, single-arm trial to assess the efficacy of a single 300 mg dose of rademikibart administered as a 2-minute IV infusion (IV push) on lung function in participants with asthma or COPD with type 2 inflammation who require an urgent healthcare visit for the treatment of acute exacerbation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Single 300 mg dose as a 2-minute IV push
Columbus Clinical Services, LLC
Miami, Florida, United States
NOT_YET_RECRUITINGPharmax Research of South Florida, Inc.
Miami, Florida, United States
RECRUITINGChange from baseline in post-BD FEV1
Time frame: 1 week
Change from baseline in post-BD FEV1 at scheduled timepoints
Time frame: Days 1, 2, 3, 14, 28, and 42
Incidence of treatment-emergent adverse events
Time frame: 42 days
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