Guillain-Barre Syndrome (GBS)Phase 2/3NCT06885762
Efgartigimod for the Treatment of Guillain-Barré Syndrome
A Phase 2/3 study testing efgartigimod in people with Guillain-Barre Syndrome (GBS), run by Zhongming Qiu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barre Syndrome (GBS)
- What is being tested?
- efgartigimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2025to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Written informed consent obtained.
Who cannot join
- 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;
- Vaccination within 4 weeks prior to screening or planned vaccination during the study period;
- Pregnant or breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential not using effective contraception;
Show all 10Show fewer
- Currently participating in another clinical trial of similar investigational agents (FcRn antagonists);
- Use of the investigational drug within 3 months prior to screening or within five half-lives of the drug (whichever is longer);
- 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;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Efgartigimod in Guillain-Barré Syndrome
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)
- Being tested
- efgartigimod
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efgartigimodDrug
efgartigimod 20 mg/kg was administered via intravenous infusion on day 1 and day 5 of the treatment period only.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: efgartigimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guillain-Barré Syndrome Disability Scale (GBS-DS)
The mean time to first achieve a GBS-DS score of ≤1 within 12 weeks.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start13 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre Syndrome (GBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885762
- Sponsor's protocol ID
- 2025-010-01
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Efgartigimod in Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT06885762
- Acronym / sponsor ID
- 2025-010-01
- Conditions
- Guillain-Barre Syndrome (GBS)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Study start
- 13 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: efgartigimod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Written informed consent obtained.
Key exclusion criteria (10 listed)
- 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;
- Vaccination within 4 weeks prior to screening or planned vaccination during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efgartigimodefgartigimod 20 mg/kg was administered via intravenous infusion on day 1 and day 5 of the treatment period only. | Drug | Treatment group |
Primary outcome
Guillain-Barré Syndrome Disability Scale (GBS-DS)
Time frame: 12 weeks.
The mean time to first achieve a GBS-DS score of ≤1 within 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Related trials for Guillain-Barre Syndrome (GBS)
Not yet recruitingPhase 2
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
Guillain-Barré Syndrome (GBS)
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Recruiting
Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome
Guillain-Barre Syndrome
RecruitingObservational study
Cohort Study on Neuroimmune Diseases in the Reproductive Age
Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis
RecruitingObservational study
Firm Observational Clinical Unicenter Study on Guillain Barré Syndrome
Guillain-Barre Syndrome (GBS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing efgartigimod in people with Guillain-Barre Syndrome (GBS), run by Zhongming Qiu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyou Meng (0086-023-68774449, mengzhaoyou@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guillain-Barré Syndrome Disability Scale (GBS-DS) (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.