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Efgartigimod in Anti-NMDA Receptor Encephalitis.

Study acronym: ANSWER
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This study is a multicenter, open-label, single-arm exploratory trial designed to enroll 20 eligible patients with anti-NMDAR encephalitis. It aims to evaluate the efficacy and safety of efgartigimod in the acute phase of anti-NMDAR encephalitis. The study drug is efgartigimod, α injection administered intravenously at a dose of 10 mg/kg (maximum dose 1200 mg). Each infusion lasts approximately 1 hour, administered weekly for a total of 4 doses. The primary endpoint is the change in modified Rankin Scale (mRS) score at week 4 (day 28) post-treatment compared to baseline.
Trial Details
NCT Number NCT07822776
Lead Sponsor Beijing Tongren Hospital
Collaborators: Henan Provincial People's Hospital, First Affiliated Hospital of Zhejiang University, Shandong Provincial Hospital, Peking Union Medical College, The Second Hospital of Hebei Medical University, Xijing Hospital, Beijing Huaxin Hospital
Conditions
(from sponsor)		 Encephalitis Autoimmune
Related terms Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Autoimmune Diseases of the Nervous System
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov