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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))

NCT07034209 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Hemophagocytic Lymphohistiocytoses

Interventions

DRUG

Plonmarlimab

Subjects receive Plonmarlimab 6 mg/kg or 10 mg/kg, administered intravenously, once weekly for 8 weeks.

Sponsors & Collaborators

  • TJ Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034209 on ClinicalTrials.gov