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Tests treatment safety and results for Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Official title Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
ClinicalTrials.gov ID: NCT06510283
What this study is testing
What is Taitacept?
Taitacept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for anti-n-methyl-d-aspartate receptor encephalitis.
Also referred to as No other Intervention Names.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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
You likely can't join if
- 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\ 1.5×ULN TBil(total bilirubin)...
- 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...
- Exclude patients who are positive for hepatitis C antibodies ;
See the full eligibility criteria
- 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)
- Seizures
- 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...
- 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...
- 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\ 1.5×ULN TBil(total bilirubin) \>1.5×ULN ALT\>3× ULN AST\>3× ULN Alkaline phosphatase\>2× ULN Creatine...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.