NCT06510283招募中2 期
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- the change of mRS score
研究概览
简要总结
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.
Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥14 years old, male or female;
- •Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
- •Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:
- •Rapid onset (<3 months) of at least four of the following six major symptoms:
- •Abnormal (mental) behavior or cognitive dysfunction
- •Speech dysfunction (verbal urgency, hypospeech, mutism)
- •Movement disorders, dyskinesias, or postural rigidity/abnormalities
- •Decreased level of consciousness
- •Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms;
- •Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and/or cerebrospinal fluid LGI1 antibody; c．Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes (e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis);
- •Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours）;Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase>1); 5）Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6）Ability to obtain patient or proxy consent; 7）Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept;
排除标准
- •History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
- •Abnormal laboratory indicators, including but not limited to the following indicators:
- •White blood cell count<3×10^9 /L Neutrophil count<1.5×10^9 /L Hemoglobin<85g/L Blood platelet count<80×10^9 /L Serum creatinine>1.5×ULN TBil(total bilirubin) >1.5×ULN ALT>3× ULN AST>3× ULN Alkaline phosphatase>2× ULN Creatine kinase>5× ULN
- •Evidence of active infection such as shingles, HIV or active tuberculosis, etc.
- •Currently have active hepatitis or have severe liver disease and a history of it.
- •Patiens with abnormal Hepatitis B test as follows should be excluded: HbsAg positive; HbsAg negative but HbcAb positive, and HBV-DNA positive. Whereas patients with HbsAg negative but HbcAb positive, and HBV-DNA negative can be included.
- •Exclude patients who are positive for hepatitis C antibodies ;
- •Uncontrolled diabetes mellitus: Glycosylated hemoglobin>9.0% or fasting blood glucose≥11.1mmol/L;
- •Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study;
- •Received rituximab or other biological therapies within 1 month prior to enrollment;
- •Malignancy;
- •Allergic to human biological products;
- •Participated in any clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug participating in the clinical trial
- •Patients who plan to have children during the trial, or who are pregnant or breastfeeding;
- •Alcohol or drug abuse/addiction is known to have an impact on compliance with trial requirements;
- •Patients who are deemed unsuitable for the trial by the investigator (e.g., those with severe mental disorders).
研究组 & 干预措施
Taitacept treatment group
Experimental
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.
干预措施: Taitacept (Drug)
结局指标
主要结局
the change of mRS score
时间窗: from baseline at week 24
Refractory encephalitis: rate of patients with mRS score \<2 or mRS score improvement of ≥2 points from baseline at week 24; Recurrent encephalitis: proportion of patients with no recurrence and \[mRS score \<2 or mRS score improvement of ≥2 points from baseline at week 24. mRS score vary from 0-6 score and higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Telitacicept Followed With Rituximab Therapy on APS Secondary to SLEAntiphospholipid SyndromeNCT05644210Qilu Hospital of Shandong University80
进行中（未招募）
不适用
A Study of Telitacicept for IgA Nephropathy (TELIGAN)NCT05799287RemeGen Co., Ltd.318
招募中
4 期
Efficacy and Safety of Telitacicept in Early SLELupus Erythematosus, SystemicNCT05899907Peking Union Medical College Hospital180
已完成
3 期
Study of Telitacicept in Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedNCT05737160RemeGen Co., Ltd.114
撤回
3 期
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)Systemic Lupus ErythematosusNCT06456567Vor Biopharma350