Efgartigimod for the Treatment of Guillain-Barré Syndrome

NCT ID: NCT06885762

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-13
• Study Completion Date: 2026-12-31

Brief Summary

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

Conditions

Guillain-Barre Syndrome (GBS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

efgartigimod

Intervention Type: DRUG

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

Interventions

efgartigimod

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or older;

2. Meet the diagnostic criteria as specified in the *European Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2023 Edition*;

3. Onset of GBS symptoms within 2 weeks prior to enrollment;

4. GBS-DS score of 3-5;

5. Written informed consent obtained.

Exclusion Criteria

1. Patients with GBS symptoms for more than 2 weeks;

2. Known hypersensitivity of the study subject to any component of the investigational drug or any other anti-neonatal Fc receptor (FcRn) agent;

3. Any uncontrolled active infection or severe infection within 8 weeks prior to screening;

4. 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;

5. Vaccination within 4 weeks prior to screening or planned vaccination during the study period;

6. Pregnant or breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential not using effective contraception;

7. Currently participating in another clinical trial of similar investigational agents (FcRn antagonists);

8. Use of the investigational drug within 3 months prior to screening or within five half-lives of the drug (whichever is longer);

9. 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;

10. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongming Qiu

OTHER

Sponsor Role: lead

Responsible Party

Zhongming Qiu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Zhaoyou Meng

Role: CONTACT

mengzhaoyou@tmmu.edu.cn

0086-023-68774449

Other Identifiers

2025-010-01

Identifier Type: -

Identifier Source: org_study_id