Efgartigimod for the Treatment of Guillain-Barré Syndrome

ConditionGuillain-Barre Syndrome (GBS)

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorZhongming Qiu

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Guillain-Barré Syndrome Disability Scale (GBS-DS)

The mean time to first achieve a GBS-DS score of ≤1 within 12 weeks.

Time frame

12 weeks.

Locations

This trial has no locations.

Sponsors and contacts

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

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Source ClinicalTrials.gov

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