NCT07583641 A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
| NCT ID | NCT07583641 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | argenx |
| Condition | Autoimmune Encephalitis (AE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2029-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 170 participants in total. It began in 2026-08-15 with a primary completion date of 2029-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07583641 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Autoimmune Encephalitis (AE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07583641 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07583641 currently recruiting?
Yes, NCT07583641 is actively recruiting participants. Contact the research team at Clinicaltrials@argenx.com for enrollment information.
Where is the NCT07583641 trial being conducted?
This trial is being conducted at Tucson, United States, Sherman, United States.
Who is sponsoring the NCT07583641 clinical trial?
NCT07583641 is sponsored by argenx. The trial plans to enroll 170 participants.