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

NCT06510283 | Recruiting Phase 2

• 1 other identifier: TREC2024-KY061
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Outcome Measures

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.

  from baseline at week 24

Study Arms (1)

Taitacept treatment group

EXPERIMENTAL

Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.

Drug: Taitacept

Interventions

Taitacept DRUG

Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.

Also known as: No other Intervention Names

Taitacept treatment group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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
• 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;
• 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;

You may not qualify 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\<3×10\^9 /L Neutrophil count\<1.5×10\^9 /L Hemoglobin\<85g/L Blood platelet count\<80×10\^9 /L Serum creatinine\>1.5×ULN TBil(total bilirubin) \>1.5×ULN ALT\>3× ULN AST\>3× ULN Alkaline phosphatase\>2× ULN Creatine kinase\>5× ULN
• 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.
• 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;

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital,Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jiawei Wang

  Beijing Tong Ren Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiawei Wang, PHD

CONTACT

010-58266091; pengyujing1206@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)