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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Therapy | Drug | Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated. |
|
| 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 |
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D000305 | Adrenal Cortex Hormones |
| D007166 | Immunosuppressive Agents |
| C000722462 | telitacicept |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Telitacicept | Drug | Telitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks. |
|
Change from baseline in serum immunoglobulin G levels during the study period. |
| Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24 |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |