Health TrialsbyHealthPanel

Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome(GREAT)

ConditionGuillain-Barré Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Tiantan Hospital

About this trial

The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS). The main questions it aims to answer are:

Is Efgartigimod a safe treatment option for GBS patients? Does treatment with Efgartigimod improve patient outcomes?

Participants will:

Take drug Efgartigimod or Intravenous Immunoglobulin during hospitalization Undergo six blood draws in six follow-up study visits to evaluate the concentration of IgG Keep a diary of their symptoms and drugs using at the same time

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-70 years

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).

Onset of GBS within 14 days

GBS Disability Scale (GBS-DS) score of 3 to 5

Disqualifiers

Patients with other diagnoses cannot be excluded

Patients with recurrent GBS

Patients with more than 14 days after onset of symptoms

GBS DS of 2 or less

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous immunoglobulin (IVIG)

    Drug

    IVIg is the standard-of-care treatment for GBS. The same brand of intravenous immunoglobulin (IVIG) was administered across different study sites

  • Efgartigimod Alfa-Fcab

    Drug

    Efgartigimod is an anti-neonatal Fc receptor (FcRn) immunoglobulin G1 Fc fragment. The FcRn plans a critical role in extending the half-life of IgGs by rescuing them from lysosomal degradation. Antibodies that bind and subsequently block the FcRn with high affinity result in IgGs being degraded more rapidly instead of salvaged. This approach has been shown to be beneficial in the antibody-mediated disorder myasthenia gravis.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Intravenous Immunoglobulin (IVIg)Active comparator 1 intervention
Group B: Efgartigimod Alfa-FcabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Guillain-Barre Syndrome Disability Scale (GBS-DS)

Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.

Time frame
week 4
2

Number and seriousness of adverse events

safety monitoring

Time frame
Through study completion, an average of 2 years

Secondary outcomes

1

Guillain-Barre Syndrome Disability Scale (GBS-DS)

Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.

Time frame
week 1，2，3，8，12，24
2

Change from baseline in Guillain-Barre Syndrome Disability Scale (GBS-DS)

Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.

Time frame
week 1,2,3,4,8,12,24
3

Number of days to GBS-DS ≤2 within 24 weeks

Time frame
24 weeks
4

Proportion of patients with GBS-DS ≤2

Time frame
week 1, 2, 3, 4, 8, 12, and 24

Other outcomes

1

Study effect of Efgartigimod on IgG levels

Blood sample to analyze change in IgG levels

Time frame
week 1, 2, 3 ,4 ,8 ,12 ,24

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: