Clinical Trials

Are You Or Is Your Child Diagnosed With Autoimmune Encephalitis (AIE)?

Advance Junior study website

Investigational Study Drug

Efgartigimod PH20 SC

Study Status
Not yet recruiting

Clinical Study Code

ARGX-113-22-AIE-2001

Clinicaltrials.Gov Number

NCT07583641

About AIE

About AIE

Autoimmune encephalitis (AIE) is a condition in which the brain becomes inflamed. This happens when the immune system (for example, antibodies or certain immune cells), which normally fights infections, mistakenly attacks the brain. The exact cause of AIE is not always known, but in some cases it may be triggered by certain cancers, infections, or medicines. Without treatment, AIE can lead to serious and sometimes long-lasting symptoms.

About this study

Phase

2

Number of participants

Approx. 170

Start date

July 2026

Study sites

Approx. 155

The Polaris study is designed to evaluate how well the investigational study drug* may work (called “efficacy”) and how safe it is for people diagnosed with AIE.

*The investigational study drug, efgartigimod PH20 SC, is not approved by any regulatory agency for the use in AIE, as efficacy and safety have not been established.

Eligibility

You may be eligible to participate if you are:

  • At least 12 years of age
  • Diagnosed with AIE

Additional criteria apply in order to participate, which the study doctor will discuss with you.

What to expect

Screening –

Up to 4 weeks 

Treatment – 

Up to 13 months

Follow up –

Up to 18 Months

Joining the study means that participation will be for up to 3 years maximum. During this time, participants may need to visit the study site approximately 40 times.

Some of these visits may be done at home or at another location.

The study consists of 4 parts:

  • Screening period: Up to 4 weeks.
  • Treatment period:
    • Part A (about 2 months): Participants will receive the investigational study drug.
    • Part B (about 5.5 months): Participants will receive the investigational study drug or placebo.
    • Part C (about 5.5 months): Participants will receive the investigational study drug.
  • Follow-up period (about 18 months): Participants will be observed after their last dose of investigational study drug. If AIE symptoms return, the investigational study drug may be restarted during this time. When you finish the study, you will stop the investigational study drug.

Study locations

The clinical study sites are located across the world. Discover open study sites on the map.

Discover Locations for This Study

Select a Country
  • All