The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).
This study will consist of a 4-week Screening period, 13-week Primary Treatment period, and optional Extended Treatment period (up to 2 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Alexion Study Site
Whittier, California, United States
Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline
Time frame: Baseline (Day 1) through Day 92
Total Number Of Units Of Packed Red Blood Cells (pRBCs) Transfused
Time frame: Day 15 through Day 92
Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
Time frame: Baseline, Day 92
Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via Functional Assessment Of Cancer Therapy Anemia (FACT-AN) Questionnaire
Time frame: Baseline, Day 92
Number Of Weekly Hgb Measurements With Change From Baseline ≥ 2 g/dL
Time frame: Day 1 through Day 92
Number Of Participants Needing New WAIHA Rescue Medication Or Increase In Dose Of WAIHA Medication
Time frame: Day 15 through Day 92
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