Study on the Efficacy and Safety of Telitacicept in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change From Baseline in Timed Up and Go Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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 ≥
- •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
- •(4) Able to fully understand the study, willing to comply with study procedures, and able to provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Telitacicept (Drug)
Conventional Therapy Group
Participants in this group will receive conventional therapy, including intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.
干预措施: Conventional Therapy (Drug)
结局指标
主要结局
Change From Baseline in Timed Up and Go Test
时间窗: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Timed Up and Go test.
Percentage of Participants With Confirmed Evidence of Clinical Improvement
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 Mean Grip Strength
时间窗: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in mean grip strength.
次要结局
- 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)
研究者
Cunjin Zhang
Principal Investigator
Sichuan Provincial People's Hospital