drugset / Trial / NCT07190261

A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

NCT07190261 ↗

Phase 2 Not yet recruiting 3 enrolled Bing Han
NaParallel-groupOpen-labelTreatment

Summary

Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.

Timeline

Start
2025-09-18
Primary completion
2027-09-18
Completion
2027-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Enatumab Unknown 38 mg Subcutaneous