Telitacicept for Refractory Chronic Inflammatory Demyelinating Polyneuropathy
Condition(s) studied
Investigational drug(s) / intervention(s)
Conventional Therapy: Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.
Telitacicept: Telitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks.
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Confirmed Evidence of Clinical Improvement — Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Percentage of participants with confirmed evidence of clinical improvement, defined according to prespecified improvements in CIDP-related clinical and functional assessments. - Change From Baseline in Adjusted INCAT Disability Score — Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the adjusted Inflammatory Neuropathy Cause and Treatment disability score. - Change From Baseline in MRC Sum Score — Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Medical Research Council sum score. - Change From Baseline in I-RODS Score — Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Inflammatory Rasch-built Overall Disability Scale score. - Change From Baseline in Timed Up and Go Test — Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Timed Up and Go test. - Change From Baseline in Mean Grip Strength — Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in mean grip strength.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan |
More Sichuan Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07597733 on ClinicalTrials.gov ↗ ← All trials in China