What this study is
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
What's being tested
- Efgartigimod PH20 (ARGX-113) SC
Intervention · BIOLOGICAL
subcutaneous administrations of efgartigimod PH20 SC given by prefilled syringe (PFS). For participants aged 12 to <18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe.
- Placebo PH20 SC
Intervention · OTHER
subcutaneous administrations of placebo PH20 SC given by prefilled syringe (PFS). For participants aged 12 to <18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe
Study details
- Official title
- A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult and Adolescent Participants With Autoimmune Encephalitis
- Sponsor
- argenx
- Conditions
- Autoimmune Encephalitis (AE)
- Enrolling
- 170 people
- Starts
- 2027-04-01
- Est. completion
- 2030-07-30
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years and overSex ALLHealthy volunteers Not acceptedPart A
You may qualify 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
You can't join 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.
Part B
You may qualify if
- Is at least 12 years of age.
- Meeting at least the criteria for possible AIE according to the Graus criteria.
- 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openCenter for Neurosciences
Tucson, Arizona, United States
- Gwendolyn Grabiec · Contact(520) 529-5234ggrabiec@neurotucson.com
- Francisco Valdivia · Principal investigator
Texas Institute for Neurological Disorders
Sherman, Texas, United States
- Laurie Laurie · Contact(903) 893-5141 x4358ljarvis@texasneurologyinstitute.com
- Bharathy Sundaram · Principal investigator
Study team
Sponsor
argenx
Study ID ARGX-113-22-AIE-2001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.