Can an antibody-clearing drug blunt a brain-attacking immune attack?
NCT ID NCT07822776
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing efgartigimod, an intravenous drug that reduces certain antibodies, in adults with anti-NMDAR encephalitis, a rare autoimmune condition that causes psychiatric symptoms, seizures, and movement problems. The trial enrolls 20 participants who receive four weekly infusions of efgartigimod at 10 mg/kg. The main goal is to see whether neurological disability, measured by the modified Rankin Scale, improves by week 4 compared with the start of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- efgartigimod alfa, an antibody-based drug given by intravenous infusion
- What this could lead to
- If it works, efgartigimod could offer a faster way to reduce neurological disability during the acute phase of anti-NMDAR encephalitis, possibly shortening hospital stays and improving recovery.
- What could go wrong
- This is a small, single-arm phase 2 pilot with 20 participants and no comparison group, so any improvement could reflect natural recovery or standard care. Efgartigimod can lower antibody levels and may raise the risk of infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Diagnosed as anti-NMDAR encephalitis, diagnostic criteria as follows: 1. At least one of the following six major symptoms: * Abnormal (mental) behavior or cognitive dysfunction * Speech dysfunction (verbal urgency, hypospeech, mutism) * Seizures * Movement disorders, dyskinesias, or postural rigidity/abnormalities * Decreased level of consciousness * Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms; 2. Positive anti-NMDAR IgG antibody: Diagnosis should be based on CSF antibody positivity using CBA. If only serum samples are available for testing, a positive CBA result must be supplemented with TBA on cultured neurons for definitive confirmation. Serum positivity at low titers (1:10) is not diagnostically significant. c.Reasonable exclusion of other etiologies. 3. Patients with newly diagnosed or relapsed anti-NMDAR encephalitis who scored ≥2 on the mRS (5 patients each with mRS scores of 2-5); * Newly diagnosed patients must not have received any prior immunosuppressive therapy. * For relapsed patients: 1. For subjects receiving rituximab, treatment must have commenced at least 2 months prior to screening, with the final dose administered no less than 4 weeks before randomization, and no improvement in mRS score within the 4 weeks preceding randomization. 2. For subjects receiving other immunosuppressive agents (i.e., mycophenolate mofetil, cyclophosphamide, or azathioprine), treatment must have been ongoing for at least 2 months prior to screening, the dose must have been stable for at least 4 weeks prior to screening, and there must have been no improvement in the mRS score within 4 weeks prior to randomization. 3. For subjects receiving oral corticosteroids, those receiving a stable daily dose of ≥20 mg of prednisolone (or its equivalent) with no increase in steroid dosage within 4 weeks prior to screening, and no improvement in mRS score within 4 weeks prior to randomization. 4. For subjects receiving repeated courses (pulse therapy) of acute first-line therapy, treatment must be completed \>2 weeks prior to randomization (baseline visit). 4. Study subjects had received at least 3 days of glucocorticoid therapy at a dose of 500-1000 mg MP daily within 2 weeks prior to enrollment (baseline visit). They had transitioned to oral corticosteroid therapy and stable doses of non-steroidal immunosuppressive agents (NISIT) (limited to relapsed patients), and had not received IVIG or plasma exchange. 5. For women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose of Efgartigimod. 6. Ability to sign an informed consent form, which includes agreeing to comply with the requirements and restrictions outlined in the informed consent form and this protocol. Exclusion Criteria: Subjects should be excluded from the study if they meet any of the following criteria: 1. Presence of any untreated teratoma or thymoma at baseline visit. Detection of teratoma or thymoma prior to or during the screening period is permitted if the disease is considered cured following treatment (typically surgical resection) within 1 week before baseline. 2. Known allergy to any component of the study drug or any other anti-FcRn drug. 3. Received IVIG or PE therapy within 2 weeks prior to screening. 4. Research participants with clinically significant active infections (including unresolved or inadequately treated infections) as assessed by the investigator. 5. Malignancies requiring chemotherapy. 6. Total IgG level ≤6 g/L in study subjects during screening visits. 7. Pregnancy 8. Patients with severe underlying conditions such as cardiac insufficiency, arrhythmia, or coagulation disorders.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Encephalitis autoimmune are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beijing Tongren Hospital,Capital Medical University, Beijing, Beijing 100730
RECRUITINGBeijing, 102600, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.