drugset / Trial / NCT07597733

Telitacicept for Refractory Chronic Inflammatory Demyelinating Polyneuropathy

NCT07597733

Active not recruiting 76 enrolled Sichuan Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of Telitacicept in patients with refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Eligible patients will be randomly assigned to receive either conventional therapy alone or Telitacicept plus conventional therapy for 24 weeks. Efficacy will be assessed using CIDP-related clinical and functional measures, including the Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), Medical Research Council (MRC) sum score, grip strength, and the Timed Up and Go (TUG) test. Safety will be evaluated by monitoring adverse events, including their onset, duration, clinical manifestations, and management.

Timeline

Start
2025-09-26
Primary completion
2027-08-31
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Telitacicept Protein / enzyme biologic Subcutaneous