Can a new drug shorten Guillain-Barré recovery?
NCT ID NCT07806916
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether efgartigimod, a drug that lowers harmful antibody levels, can improve recovery in people with Guillain-Barré syndrome (GBS), a rare nerve condition that can cause weakness and paralysis. Adults aged 18 to 70 with recent GBS onset will receive either efgartigimod or standard intravenous immunoglobulin (IVIG) during hospitalization. Researchers will track disability scores and safety over six follow-up visits to see if efgartigimod offers better outcomes than the current standard care.
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-fcab, an experimental drug that lowers harmful antibody levels, compared with standard intravenous immunoglobulin (IVIG)
- What this could lead to
- If efgartigimod works, it could offer a new treatment option for Guillain-Barré syndrome that speeds recovery and reduces disability.
- What could go wrong
- This is an early phase 2 trial with 110 participants, so results may not hold up in larger studies. The drug also carries risks like infections and infusion reactions.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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. Aged 18-70 years 2. Diagnosis of sensorimotor or pure motor Guillain-Barré syndrome (GBS) based on the 2023 EAN/PNS guidelines (corresponding to classical GBS in the Chinese Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2024). 3. Onset of GBS within 14 days 4. GBS Disability Scale (GBS-DS) score of 3 to 5 Exclusion Criteria: 1. Patients with other diagnoses cannot be excluded 2. Patients with recurrent GBS 3. Patients with more than 14 days after onset of symptoms 4. GBS DS of 2 or less 5. Patients unable to cooperate with scale assessments due to psychiatric disorders or impaired consciousness 6. Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection; Hepatitis C virus (HCV) based on HCV antibody assay; Positive HIV serology at screening 7. Patients with any known severe bacterial, viral or fungal infection or any major episode of infection that required hospitalization or injectable antimicrobial therapy in the last 8 weeks prior to Screening 8. Total IgG level ≤ 6 g/L at screening 9. Concomitant diseases that can cause peripheral neuropathy, such as metabolic neuropathies (e.g., diabetes, alcoholism), connective tissue disease-associated neuropathies (e.g., rheumatoid arthritis, Sjögren's syndrome, systemic lupus erythematosus), or trauma, which may confound the trial results 10. Subjects with serious underlying diseases, such as cardiac dysfunction, coagulopathy dysfunction 11. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing 12. Patients who have a history of malignancy, including malignant thymoma, or myeloproliferative or lymphoproliferative disorders, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 3 years before Screening. Patients with completely excised non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ would be permitted at any time 13. Use of investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to Screening 14. Use of immunosuppressants, monoclonal antibodies, or other immunomodulatory drugs within 6 months prior to enrollment; use of corticosteroids at a dose exceeding 20 mg within 3 months prior to enrollment; or use of IVIG or plasma exchange (PE) within 1 month prior to enrollmen
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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