drugset / Trial / NCT07208058

A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])

NCT07208058

Phase 3 Recruiting 30 enrolled TJ Biopharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

A study designed to evaluate the efficacy, safety, immunogenicity, PK, and PD characteristics of Plonmarlimab in patients with relapsed/refractory rheumatic and immunologic disease-associated MAS, and to explore biomarkers related to the efficacy of Plonmarlimab.

Timeline

Start
2025-11-21
Primary completion
2026-12-20
Completion
2027-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Plonmarlimab Monoclonal antibody 6 mg/kg Intravenous