This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
After being informed of study details and potential risks, all participants who provide written informed consent will undergo an up to 6-week screening period to determine eligibility. Participants who meet the eligibility criteria will receive two once-weekly intravenous (IV) infusions of ANX005. Participants will return to the clinic weekly through Week 10 for study assessments. The total duration of individual participation in this study will be up to 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
ANX005 is provided as a solution for IV infusion
Investigational Site 01
Rochester, Minnesota, United States
Safety: Treatment-emergent adverse events (TEAEs)
Number of participants with TEAEs, defined as any adverse event with an onset on or after the day of infusion through 16 weeks after the infusion
Time frame: Up to Week 16
Change in disease activity biomarkers
Change in hemoglobin, lactate dehydrogenase, bilirubin, reticulocyte count and haptoglobin from baseline
Time frame: Baseline to Day 71
Plasma concentrations
Plasma concentrations of ANX005 over time
Time frame: Up to Day 71
Change in complement system biomarkers
Change in CH50 and C1q from baseline
Time frame: Baseline to Day 71
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