Clinical Trial

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])

Recruiting Phase 3
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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.
Protocol Amendment History 1 change
notable Trial sites expanded: 15 -> 18 locations 2026-07-21
Trial Details
NCT Number NCT07208058
Lead Sponsor TJ Biopharma Co., Ltd.
Conditions Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis
Enrollment 30 participants
Start Date 2025-11-21
Primary Completion 2026-12-20 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-20