Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome

Conditions

• Guillain-Barre Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• Intravenous Immunoglobulin (IVIg) — DRUG
  IVIg is the standard-of-care treatment for GBS. Brand of IVIG used may vary per institutional standards

Study Details

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? In addition to standard-of-care procedures and assessments, participants will: * Undergo seven blood draws during hospitalization and in four follow-up study visits to evaluate the concentration of neurofilament light chain, a protein that is elevated in patients with Guillain-Barré syndrome. The presence of neurofilament light chain is believed to be indicative of damage to the nervous system, with higher levels resulting from greater damage. * Complete the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor any suicidal ideation or behaviors during the course of the study.

Key Dates

Start date

Sep 10, 2024

Status verified

Mar 2026

Primary completion

Jan 19, 2026

Completion

Feb 20, 2026

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Efgartigimod Alfa-Fcab
  20mg/kg of Intravenous efgartigimod on days 1 and 5, with normal saline administered as placebo on days 2-4
• Active Comparator: Intravenous Immunoglobulin (IVIg)
  0.4g/kg of IVIg daily for 5 days

Primary Outcome Measure

Guillain-Barre Syndrome Disability Scale (GBS-DS) [ Time Frame: Week 4 ]

Locations (1)

Find similar trials in Philadelphia, PA

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• An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
  PHASE3 · Recruiting · Annexon, Inc. · Phoenix, Arizona