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A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
Sponsor: Zenas BioPharma (USA), LLC
Summary
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With An Open Label Safety and Dose Confirmation Run-In Period, To Evaluate the Efficacy and Safety of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2023-09-25
Completion Date
2026-08-31
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Placebo
Placebo
Locations (7)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, Poland
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
National Cheng Kung University Hospital
Tainan, Taiwan
Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom