Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Enc… (NCT06510283) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
China10 participantsStarted 2024-12-01
Plain-language summary
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.
Who can participate
Age range14 Years
SexALL
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Inclusion 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:
Exclusion criteria
✕. 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;
✕. 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:
✕. 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.
✕. Uncontrolled diabetes mellitus: Glycosylated hemoglobin\>9.0% or fasting blood glucose≥11.1mmol/L;