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ACTIVE NOT RECRUITING
NCT05786573
PHASE3

A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Obexelimab

Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.

DRUG

Obexelimab

Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.

OTHER

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