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Not yet recruiting NCT06885762

Efgartigimod for the Treatment of Guillain-Barré Syndrome

Phase II / Phase III Interventional Guillain-Barre Syndrome (GBS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: efgartigimod.
Who it may be relevant to
Registry conditions: Guillain-Barre Syndrome (GBS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Efficacy of Efgartigimod in Guillain-Barré Syndrome

Overview

The goal of this clinical trial is to evaluating the efficacy and safety of efgartigimod in the treatment of Guillain-Barré Syndrome and exploring the immunological mechanisms of efgartigimod therapy in Guillain-Barré Syndrome. The main questions it aims to answer are: Will efgartigimod improve the symptoms of participants? What medical problems do participants have when using efgartigimod? Participants will: On day 1 and day 5 of the treatment period, drug A was administered intravenously. Keep a diary of their symptoms

Interventions

  • Drug efgartigimod
    efgartigimod 20 mg/kg was administered via intravenous infusion on day 1 and day 5 of the treatment period only.

Primary outcome measures

  • Guillain-Barré Syndrome Disability Scale (GBS-DS) [Time frame: 12 weeks.]

Eligibility criteria

Inclusion criteria

  • Aged 18 years or older;
  • Meet the diagnostic criteria as specified in the \*European Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2023 Edition\*;
  • Onset of GBS symptoms within 2 weeks prior to enrollment;
  • GBS-DS score of 3-5;
  • Written informed consent obtained.

Exclusion criteria

  • Patients with GBS symptoms for more than 2 weeks;
  • Known hypersensitivity of the study subject to any component of the investigational drug or any other anti-neonatal Fc receptor (FcRn) agent;
  • Any uncontrolled active infection or severe infection within 8 weeks prior to screening;
  • Patients with other autoimmune diseases, such as Sjögren's syndrome, systemic lupus erythematosus, neuromyelitis optica, myasthenia gravis, multiple sclerosis, etc., requiring treatment with immunosuppressive agents;
  • Vaccination within 4 weeks prior to screening or planned vaccination during the study period;
  • Pregnant or breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential not using effective contraception;
  • Currently participating in another clinical trial of similar investigational agents (FcRn antagonists);
  • Use of the investigational drug within 3 months prior to screening or within five half-lives of the drug (whichever is longer);
  • Patients with a history of malignancy, including malignant thymoma, myeloproliferative or lymphoproliferative disorders, unless considered cured by adequate treatment and without evidence of recurrence for ≥3 years prior to screening. Patients with completely resected non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix are eligible at any time;
  • Patients with clinical evidence of other significant severe diseases or who have recently undergone major surgery, which may confound study results or place the patient at undue risk. Patients with severe renal/hepatic impairment may be included.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06885762 · 2025-010-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗