Telitacicept for Refractory Chronic Inflammatory Demyelinating Polyneuropathy

Study on the Efficacy and Safety of Telitacicept in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Refractory Chronic Inflammatory Demyelinating Polyneuropathy
• Intervention / Treatment: Drug: Conventional Therapy; Drug: Telitacicept

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: (1) Male or female participants aged 18 to 65 years, inclusive.

(2) Diagnosis of refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Refractory CIDP is defined as the absence of evidence of clinical improvement (ECI) after at least 1 month of at least one first-line therapy, including intravenous immunoglobulin, corticosteroids, or plasma exchange, or a persistently elevated INCAT disability score of ≥2. ECI is defined as meeting at least one of the following criteria: a. A decrease of ≥1 point in the adjusted INCAT disability score; b. An increase of ≥4 points in the I-RODS total score; c. An increase of ≥3 points in the MRC sum score; d. An improvement of ≥8 kPa in grip strength. (3) INCAT disability score of 2 to 9. (4) Able to fully understand the study, willing to comply with study procedures, and able to provide written informed consent.

Exclusion Criteria:

1. Progressive neurological disease unrelated to CIDP.
2. Limb numbness or weakness caused by other etiologies, including but not limited to hereditary demyelinating neuropathy, neuropathy secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathy, multifocal motor neuropathy, polyneuropathy associated with IgM monoclonal gammopathy, POEMS syndrome, cerebral infarction, acute myelitis, multiple sclerosis, neuromyelitis optica spectrum disorder, or other conditions that may cause limb numbness or muscle weakness.
3. Active hepatitis or severe hepatic dysfunction, defined as liver function test values greater than two times the upper limit of normal. Participants who are positive for hepatitis B surface antigen (HBsAg) will be excluded. Participants who are positive only for hepatitis B core antibody (HBc-Ab) must undergo quantitative HBV-DNA testing and will not be excluded if the result is negative.
4. Severe renal impairment, including acute kidney injury or chronic kidney disease, or serum creatinine clearance <60 mL/min calculated using the Cockcroft-Gault equation.
5. Current pregnancy, breastfeeding, or planned pregnancy within 48 weeks.
6. Participation in another interventional clinical trial within 28 days before enrollment or within five half-lives of the investigational drug, whichever is longer.
7. History of splenectomy.
8. History of allergic reactions to contrast agents or intravenously administered human-derived biological products.
9. Severe psychiatric symptoms that preclude cooperation with study procedures.
10. Treatment with B-cell-depleting agents, such as rituximab, within 6 months before enrollment, or failure of B-cell counts to recover to the normal range, whichever is longer.
11. Active tuberculosis.
12. Diabetes mellitus.
13. Failure to complete serum ganglioside antibody testing to exclude other diseases.
14. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Therapy Group; Participants in this group will receive conventional therapy, including intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.	Drug: Conventional Therapy; Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.; Other Names: Corticosteroids; Intravenous immunoglobulin; Immunosuppressive agents
Experimental: Telitacicept Plus Conventional Therapy Group; Participants in this group will receive Telitacicept in addition to conventional therapy for 24 weeks. Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.	Drug: Telitacicept; Telitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Confirmed Evidence of Clinical Improvement	Percentage of participants with confirmed evidence of clinical improvement, defined according to prespecified improvements in CIDP-related clinical and functional assessments.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Adjusted INCAT Disability Score	Change from baseline in the adjusted Inflammatory Neuropathy Cause and Treatment disability score.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in MRC Sum Score	Change from baseline in the Medical Research Council sum score.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in I-RODS Score	Change from baseline in the Inflammatory Rasch-built Overall Disability Scale score.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Timed Up and Go Test	Change from baseline in the Timed Up and Go test.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Mean Grip Strength	Change from baseline in mean grip strength.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Incidence of adverse events during the study period, including the time of onset, duration, clinical manifestations, severity, relationship to study treatment, and actions taken.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Serum IgG Levels	Change from baseline in serum immunoglobulin G levels during the study period.	Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

Collaborators and Investigators

• Sponsor: Sichuan Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Pathological Conditions, Signs and Symptoms; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Immunologic Factors; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Peptides, and Proteins; Proteins; Pharmacologic Actions; Chemical Actions and Uses; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Immunoglobulin G; Immunoglobulins, Intravenous; Immunosuppressive Agents; Adrenal Cortex Hormones; telitacicept
• Other Study ID Numbers: 2025679-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No