Telitacicept for Refractory Chronic Inflammatory Demyelinating Polyneuropathy

NCT07597733 | Active Not Recruiting

• 1 other identifier: 2025679-2
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Incidence of Adverse Events

  Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

• Change From Baseline in Serum IgG Levels

  Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

Study Arms (2)

Conventional Therapy Group

ACTIVE COMPARATOR

Participants in this group will receive conventional therapy, including intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.

Drug: Conventional Therapy

Telitacicept Plus Conventional Therapy Group

EXPERIMENTAL

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

Interventions

Conventional Therapy DRUG

Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.

Also known as: Intravenous immunoglobulin, Corticosteroids, Immunosuppressive agents

Conventional Therapy Group

Telitacicept DRUG

Telitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks.

Telitacicept Plus Conventional Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• Progressive neurological disease unrelated to CIDP.
• 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.
• 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.
• Severe renal impairment, including acute kidney injury or chronic kidney disease, or serum creatinine clearance \<60 mL/min calculated using the Cockcroft-Gault equation.
• Current pregnancy, breastfeeding, or planned pregnancy within 48 weeks.
• Participation in another interventional clinical trial within 28 days before enrollment or within five half-lives of the investigational drug, whichever is longer.
• History of splenectomy.
• History of allergic reactions to contrast agents or intravenously administered human-derived biological products.
• Severe psychiatric symptoms that preclude cooperation with study procedures.
• 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.
• Active tuberculosis.
• Diabetes mellitus.
• Failure to complete serum ganglioside antibody testing to exclude other diseases.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous; Adrenal Cortex Hormones; Immunosuppressive Agents; telitacicept

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: May 19, 2026
• Study Start: September 26, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)