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
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
Treatments tested in this trial
- efgartigimod
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
Source ClinicalTrials.gov