Who may be eligible for the Efgartigimod in Anti-NMDA Receptor Encephalitis. trial?

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.

ClinicalTrials.gov record NCT07822776

Efgartigimod in Anti-NMDA Receptor Encephalitis.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Efficacy and Safety of Efgartigimod in Anti-N-methyl-D-aspartate Receptor Encephalitis: a Phase II Multicenter Single-arm Prospective Pilot Study

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old and older

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an open-label, single-arm Phase 2 study testing intravenous efgartigimod in adults with anti‑NMDAR autoimmune encephalitis. About 20 participants receive weekly infusions for four weeks. The main measure is change in modified Rankin Scale (mRS) at 4 weeks; other clinical scales and antibody/IgG levels are followed to 12 weeks.

What it is studying. The trial tests whether intravenous efgartigimod given once weekly for four weeks affects neurological disability (measured by mRS at week 4) and other clinical scores, and whether it changes anti‑NMDAR antibody levels and total IgG up to 12 weeks, while collecting safety information.

What the researchers hope to learn. To gather evidence on efgartigimod's effects on neurological function in anti‑NMDAR encephalitis and to assess safety. Secondary goals include measuring changes in clinical assessment scales (CASE, CGI, GCS, NEOS), time to a one‑point mRS improvement without rescue therapy, and changes in anti‑NMDAR antibody and total IgG levels.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study is a multicenter, open-label, single-arm exploratory trial designed to enroll 20 eligible patients with anti-NMDAR encephalitis. It aims to evaluate the efficacy and safety of efgartigimod in the acute phase of anti-NMDAR encephalitis. The study drug is efgartigimod, α injection administered intravenously at a dose of 10 mg/kg (maximum dose 1200 mg). Each infusion lasts approximately 1 hour, administered weekly for a total of 4 doses. The primary endpoint is the change in modified Rankin Scale (mRS) score at week 4 (day 28) post-treatment compared to baseline.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Efgartigimod Alfa

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Age ≥18 years old, male or female;
Diagnosed as anti-NMDAR encephalitis, diagnostic criteria as follows:
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;
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.
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:
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.
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.
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.
For subjects receiving repeated courses (pulse therapy) of acute first-line therapy, treatment must be completed >2 weeks prior to randomization (baseline visit).
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.
For women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose of Efgartigimod.
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:
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.
Known allergy to any component of the study drug or any other anti-FcRn drug.
Received IVIG or PE therapy within 2 weeks prior to screening.
Research participants with clinically significant active infections (including unresolved or inadequately treated infections) as assessed by the investigator.
Malignancies requiring chemotherapy.
Total IgG level ≤6 g/L in study subjects during screening visits.
Pregnancy
Patients with severe underlying conditions such as cardiac insufficiency, arrhythmia, or coagulation disorders.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive efgartigimod by intravenous infusion once weekly for four weeks (10 mg/kg per infusion; each infusion lasts about 1 hour). They will have clinic visits with neurological assessments using standard scales (modified Rankin Scale [mRS], CASE, CGI, GCS, NEOS) with key assessments at baseline, week 4 and week 12. The study will measure anti‑NMDAR antibody levels and total IgG and record time to any clinical improvement. The registry record reports follow-up through 12 weeks and does not detail other procedures (for example, whether spinal taps or specific blood-sampling schedules are required).

How the study is structured. Interventional, single-group, open-label Phase 2 study. All enrolled adults receive efgartigimod by IV infusion (10 mg/kg, up to 1200 mg) once a week for four doses; each infusion lasts about one hour. There is no placebo or comparison group. Main outcome is change in mRS from baseline to day 28; additional outcomes are measured through week 12.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Encephalitis Autoimmune. Does it apply to my diagnosis?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jun 25, 2026
Primary completion: Dec 31, 2027 (estimated)
Study completion: Mar 30, 2028 (estimated)
Target enrollment: 20 participants (estimated)
Last updated on registry: Sep 16, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Beijing Tongren Hospital
Collaborators: Henan Provincial People's Hospital
First Affiliated Hospital of Zhejiang University
Shandong Provincial Hospital
Peking Union Medical College
The Second Hospital of Hebei Medical University
Xijing Hospital
Beijing Huaxin Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Jiawei Wang 📞 010-58266091 ✉ wangjwcq@163.com
Yujing Peng 📞 010-58266091 ✉ pengyujing1206@163.com

Participating sites (1)

Beijing Tongren Hospital,Capital Medical University, Beijing, Beijing 100730Recruiting
Beijing, 102600 · China
- Jiawei Wang · 18811612263 · wangjwcq@163.com

Terms used on this page · explanations by MedicalUpdates.ai

open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single-arm: All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
study drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
primary endpoint: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
relapsed: A condition that improved with treatment and has since returned or worsened.
immunosuppressive: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
prior to screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
randomization: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
corticosteroids: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
women of childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
informed consent form: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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