Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorBeijing Tongren Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥14 years old, male or female;
Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
Abnormal (mental) behavior or cognitive dysfunction
Speech dysfunction (verbal urgency, hypospeech, mutism)
Disqualifiers
History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
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.
Trial design
Design model
Single group
Treatments tested in this trial
Taitacept
DrugTelitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Taitacept treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the change of mRS score
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.
Time frame
from baseline at week 24Sponsors and contacts
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Source ClinicalTrials.gov