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])

An Open-label, Single-arm, Multicenter, 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])

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis

Interventions

Type	Name	Description
DRUG	Plonmarlimab	Subjects will receive Plonmarlimab 10 mg/kg by intravenous injection once weekly from Week 1 to Week 3, and Plonmarlimab 6 mg/kg by intravenous injection once weekly from Week 4 to Week 8 (10 mg/kg QW×3 + 6 mg/kg QW×5).

Timeline

• Start date: 2025-11-21
• Primary completion: 2026-12-20
• Completion: 2027-11-30
• First posted: 2025-10-06
• Last updated: 2025-12-02

Locations

15 sites across 1 country: China