Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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., 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;

Locations
Other Locations
China
Beijing Tongren Hospital,Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Jiawei Wang, PHD
pengyujing1206@163.com
010-58266091
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 10
Treatments
Experimental: Taitacept treatment group
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.
Sponsors
Leads: Beijing Tongren Hospital

This content was sourced from clinicaltrials.gov