drugset / Trial / NCT05416307

Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

NCT05416307 ↗

Phase 2/3 Recruiting 156 enrolled Electra Therapeutics Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.

Timeline

Start
2022-05-19
Primary completion
2027-06
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ELA026 Monoclonal antibody 0.5 mg/kg Intravenous
Subject ELA026 Monoclonal antibody 1 mg/kg Intravenous
Subject ELA026 Monoclonal antibody 3 mg/kg Intravenous