A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic Characteristics, and Immunogenicity of Plonmarlimab in Subjects With Rheumatic and Immunological Disease-associated Haemophagocytic Lymphohistiocytosis (HLH) (Also Known as Macrophage Activation Syndrome (MAS))

Phase 2 Completed 18 enrolled TJ Biopharma Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

This study adopts an open-label, single-arm, multicenter design to evaluate the efficacy, safety, tolerability, immunogenicity, and PK characteristics of Plonmarlimab administration in patients with rheumatic and immunological disease-associated HLH (MAS), and to explore biomarkers related to the efficacy of Plonmarlimab.

Timeline

Start: 2023-04-07
Primary completion: 2025-04-18
Completion: 2025-04-18

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plonmarlimab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Plonmarlimab	Monoclonal antibody	10 mg/kg	Intravenous

A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic Characteristics, and Immunogenicity of Plonmarlimab in Subjects With Rheumatic and Immunological Disease-associated Haemophagocytic Lymphohistiocytosis (HLH) (Also Known as Macrophage Activation Syndrome (MAS))

Summary

Timeline

Drugs

Indications