Anti-nmdar encephalitis
Conditions
Interventions
Control group:Placebo
Experimental group:Intravenous Methylprednisolone+efgartigimod
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 14-65 years, regardless of gender; 2.Meets the diagnostic criteria for definite anti-NMDAR encephalitis, including all three of the following conditions (A, B, and C): A. At least one of the six major symptoms: Abnormal psychiatric behavior or cognitive dysfunction Speech dysfunction Seizures Movement disorder or dyskinesias Decreased level of consciousness Autonomic dysfunction or central hypoventilation B. Positive anti-NMDAR antibodies, preferably confirmed by cell-based assay (CBA) in cerebrospinal fluid. C. Reasonable exclusion of other causes. 3. A baseline mRS score of 2 to 5. 4. Receiving or not receiving intravenous methylprednisolone for 5 days (IV,500/1000mg/ day) within 1 week; 5. Patients with recurrence should have a mRs Score of <=1 for at least 2 months before the current recurrence. 6. For women of childbearing potential: agree to use appropriate contraception during treatment and for at least 3 months after the last dose of igammod. 7. Voluntarily provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to any component of the investigational drug or to any other anti-neonatal Fc receptor (FcRn) therapy. 2.Received intravenous immunoglobulin (IVIG), plasma adsorption, or plasma exchange within 4 weeks prior to screening. 3.Use of immunosuppressive monoclonal antibodies (including but not limited to rituximab, ofatumumab, belimumab, or eculizumab) within 6 months prior to screening, or B-cell counts below the lower limit of normal in patients previously treated with rituximab or ofatumumab; or use of immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, azathioprine) within the past 6 months. 4.Any uncontrolled active infection or severe infection within 8 weeks prior to the screening period. 5.Subjects who are HIV or HCV antibody positive at screening. 6.HBV surface antigen was positive at the time of screening. Subjects were negative for HBV surface antigen, positive for anti-HBV core antibody, and further testing or medical literature within 12 weeks before the screening visit confirmed HBV-DNA quantitative test > 20001U/mL. 7.History of or current Mycobacterium tuberculosis infection (positive or indeterminate interferon-gamma release assay within 12 weeks prior to screening). 8.Presence of acute liver injury (such as hepatitis) or severe liver cirrhosis (Child-Pugh class C), or any of the following: a. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal (ULN) at screening based on laboratory reference ranges; b. Total bilirubin greater than 1.5 times the ULN at screening based on laboratory reference ranges. 9.Patients with severe underlying diseases, such as heart failure, arrhythmia, or coagulation disorders. 10.Patients with thymoma, untreated teratoma, or any malignancy were excluded; however, those who had undergone teratoma resection prior to screening were not excluded. 11.Patients diagnosed with paraneoplastic encephalitis. 12.History of drug or alcohol abuse within the past year. 13.Patients with comorbid autoimmune diseases, such as Sjögren's syndrome, systemic lupus erythematosus, neuromyelitis optica spectrum disorder, myasthenia gravis, multiple sclerosis, etc., requiring immunosuppressive treatment. 14.Received vaccination within 4 weeks prior to the screening period or planned to receive vaccination during the study. 15.Pregnant or breastfeeding women, women planning to become pregnant during the study, or women of childbearing potential not using effective contraception. 16.Currently participating in other clinical trials involving similar drugs (FcRn inhibitors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an improvement of =1 point in disease disability score from baseline and no use of rescue therapy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease disability degree;Disease severity;Proportion of patients with a good outcome;The change in serum total IgG levels from baseline.;The change in serum and cerebrospinal fluid (CSF) NMDAR antibody levels from baseline.;Montreal Cognitive Assessment (MoCA) Scale;The incidence of adverse events (AEs) and serious adverse events (SAEs).; | — |
Countries
China
Contacts
Public ContactZhen Hong
West China Hospital of Sichuan University
Outcome results
None listed