Clinical Trial

A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults

Study acronym: Polaris
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE). The study consists of 4 parts: in part A participants will receive efgartigimod SC; in part B, participants will be randomized to receive either efgartigimod SC or placebo; in part C, participants who completed part B will receive efgartigimod SC; in part D, participants who completed part C will be observed after their last dose of efgartigimod SC. If AIE symptoms return, efgartigimod SC treatment may be restarted during this time. The maximum overall study duration for participants is up to 3 years. More information can be found in clinicaltrials.argenx.com/polaris
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2030-12-04 -> 2029-01-20 2026-07-21
minor Completion moved earlier: 2031-07-26 -> 2029-05-12 2026-07-21
Trial Details
NCT Number NCT07583641
Lead Sponsor argenx
Conditions Autoimmune Encephalitis (AE)
Enrollment 170 participants
Start Date 2026-07-13
Primary Completion 2029-01-20 (estimated)
Study Completion 2029-05-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-10