Clareo Health | A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
The study is designed to address the unmet need for effective immunomodulatory therapy in AIE, enrolling patients across multiple antibody-defined subgroups, with the anti-NMDAR encephalitis group serving as the primary cohort for statistical analysis.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is at least 12 years of age.
Meeting at least the criteria for possible AIE according to the Graus criteria.
Part A:
Must not have received prior treatment for AIE with PLEX or Ig (participants may have received glucocorticoids); and must not have received PLEX or Ig for any other medical condition in the last 3 months
\- Part B: Either completing Part A, or If directly entering Part B, must have received first-line treatment for AIE (i.e. corticosteroids, PLEX, and/or Ig) and have a CASE score of 3 or higher, or a score of 2 or higher in a single sub-item
You may not be if
Known anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibody positivity.
Any medical condition that would interfere with an accurate assessment of clinical symptoms of AIE.
Recent major surgery (within 3 months of screening) or intention to have major surgery during the study, except for surgeries for AIE-related teratomas and thymomas.
History (within 12 months before screening) of current alcohol, drug (including recreational or prescribed cannabinoids), or medication abuse.
Psychiatric or cognitive impairment unrelated to AIE.
