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

NCT05786573 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-06-25

No results posted yet for this study

Summary

This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

Conditions

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

Sponsors & Collaborators

  • Zenas BioPharma (USA), LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Drug
Yes

Countries

  • Italy
  • Poland
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786573 on ClinicalTrials.gov