Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia
Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, multiple ascending, dose-finding, randomized, double-blind,
placebo-controlled study to evaluate the efficacy, safety, health-related quality of life,
tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity, of up to 3 dose regimens
of ALXN1830 administered subcutaneous(ly) (SC) in the treatment of WAIHA.
This study will include 2 randomized, double-blind, placebo-controlled cohorts (Cohorts 1 and
2) to evaluate an 8-week treatment regimen, and an optional third open-label cohort (Cohort
3) to evaluate an alternative 12-week dosing regimen. Participants may continue participation
in this study at the participant's and investigator's discretion in an open-label extension
(OLE) period, consisting of monthly visits to observe participants for relapse, which will
require going back on active treatment.