Guillain-Barré Syndrome (GBS)Phase 2embridgeNCT07821762
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
A Phase 2 study testing Empasiprubart IV and Intravenous immunoglobulin (IVIg) in people with Guillain-Barré Syndrome (GBS), run by argenx.
Trial summary
The main purpose of this study is to learn whether empasiprubart, when given in addition to intravenous immunoglobulin (IVIg), helps adults with Guillain-Barré syndrome (GBS) recover and whether it is safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barré Syndrome (GBS)
- What is being tested?
- Empasiprubart IV and Intravenous immunoglobulin (IVIg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Mar 2029
- Phase
- Phase 2
- 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
- Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria
- GBS-related weakness beginning within 7 days before the first study treatment
- GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline
- Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms
- Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown.
Who cannot join
- History of a previous GBS episode or diagnosis of an atypical GBS variant
- Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency
- Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk
- IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe
- Recent treatment with IVIg except for a single IVIg dose administered during screening and within 24 hours before the first investigational medicinal product (IMP) dose for the current GBS episode or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies
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: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Efficacy and Safety of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
The main purpose of this study is to learn whether empasiprubart, when given in addition to intravenous immunoglobulin (IVIg), helps adults with Guillain-Barré syndrome (GBS) recover and whether it is safe. About 63 participants will be assigned by chance to receive either empasiprubart or placebo by intravenous infusion; all participants will also receive IVIg. The study includes screening for up to 72 hours, study treatment for the first two weeks, and follow-up through Week 67 (15 months after the last dose of study treatment). Participation lasts up to 67 weeks.
- Conditions
- Guillain-Barré Syndrome (GBS)
- Being tested
- Empasiprubart IV, Empasiprubart Placebo IV, Intravenous immunoglobulin (IVIg)
- 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.
Empasiprubart IVBiological
Intravenous infusion of Empasiprubart
Empasiprubart Placebo IVOther
Intravenous infusion of Placebo
Intravenous immunoglobulin (IVIg)Biological
Intravenous infusion of IVIg
| Study group | Role | What they receive |
|---|---|---|
| Empasiprubart + IVIg | Experimental | Participants receive empasiprubart by intravenous infusion and IVIg by intravenous infusion. Receives: Biological: Empasiprubart IV; Biological: Intravenous immunoglobulin (IVIg) |
| Placebo + IVIg | Placebo comparator | Participants receive placebo by intravenous and IVIg by intravenous infusion. Receives: Other: Empasiprubart Placebo IV; Biological: Intravenous immunoglobulin (IVIg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2 at Week 4
The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability. It has 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability. A GBS-DS score ≤2 indicates the participant is able to walk 10 meters or more without assistance.
Measured: at week 4
Secondary outcomes (22)
Number of calendar days in the intensive care unit (ICU) within the first 4 weeks of investigational medicinal product (IMP) administration
ICU means intensive care unit; IMP means investigational medicinal product
Measured: Up to 4 weeks
Number of calendar days receiving invasive mechanical ventilation within the first 4 weeks of investigational medicinal product (IMP) administration
IMP means investigational medicinal product
Measured: Up to 4 weeks
Time From First Investigational Medicinal Product (IMP) Administration to Achieving a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2
IMP means investigational medicinal product; The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability with 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability.
Measured: Up to 52 weeks
Actual values in the Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores at weeks 13 and 26
The Inflammatory Rasch-Built Overall Disability Scale (I-RODS) is a 24-item participant-reported measure of disability that assesses limitations in activities and social participation. Raw scores range from 0 to 48 and are converted to a centile metric score ranging from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations). Higher scores indicate less disability.
Measured: Up to 26 weeks
Actual values in the Overall Neuropathy Limitations Scale (ONLS) Score at weeks 13 and 26
The Overall Neuropathy Limitations Scale (ONLS) is a clinician-reported measure of functional limitations in the upper and lower limbs. The upper-limb section is scored from 0 to 5 and the lower-limb section from 0 to 7. A score of 0 indicates no limitations, while scores of 5 (upper limbs) or 7 (lower limbs) indicate no purposeful movement. Higher scores therefore indicate greater functional limitation.
Measured: Up to 26 weeks
Change from baseline in the Medical Research Council Sum Score (MRC-SS) over time
The Rasch-built Medical Research Council Sum Score (MRC-SS) is a clinician-assessed measure of muscle strength in selected upper and lower extremity muscle groups bilaterally. The resulting score ranges from 0 to 60 and is used to evaluate the severity of weakness and changes in motor function over time. Higher scores indicate better muscle strength/better outcome, while lower scores indicate greater weakness.
Measured: Up to 52 weeks
Change from baseline in the Medical Research Council Sum Score (MRC-SS) neck flexion assessment over time
The Rasch-built Medical Research Council Sum Score (MRC-SS) neck flexion assessment evaluates the strength of the neck flexion muscles. The participant is asked to flex the neck (bring the chin toward the chest) while the examiner evaluates muscle strength using a Rasch-modified MRC grading system that ranges from 0 (no visible contraction) to 3 (normal strength).
Measured: Up to 52 weeks
Change from baseline in the Guillain-Barré Syndrome Disability Scale (GBS-DS) score over time
The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability. It has 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability.
Measured: Up to 52 weeks
Actual Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores Over Time
The Inflammatory Rasch-Built Overall Disability Scale (I-RODS) is a 24-item participant-reported measure of disability that assesses limitations in activities and social participation. Raw scores range from 0 to 48 and are converted to a centile metric score ranging from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations). Higher scores indicate less disability.
Measured: Up to 52 weeks
Actual Overall Neuropathy Limitations Scale (ONLS) Score Over Time
The Overall Neuropathy Limitations Scale (ONLS) is a clinician-reported measure of functional limitations in the upper and lower limbs. The upper-limb section is scored from 0 to 5 and the lower-limb section from 0 to 7. A score of 0 indicates no limitations, while scores of 5 (upper limbs) or 7 (lower limbs) indicate no purposeful movement. Higher scores therefore indicate greater functional limitation.
Measured: Up to 52 weeks
Number of calendar days receiving invasive mechanical ventilation through week 52
Measured: Up to 52 weeks
Proportion of participants who require invasive mechanical ventilation over time and at any time through the week 52
Measured: Up to 52 weeks
Number of calendar days in the Intensive Care Unit (ICU) through week 52
ICU means intensive care unit.
Measured: Up to 52 weeks
Proportion of participants in the Intensive Care Unit (ICU) over time and at any time through week 52
ICU means intensive care unit.
Measured: Up to 52 weeks
Number of calendar days from the start of investigational medicinal product (IMP) until discharge from the acute care facility/department
IMP means investigational medicinal product
Measured: Up to 52 weeks
Number of calendar days from the start of investigational medicinal product (IMP) until discharge from the last rehabilitation unit
IMP means investigational medicinal product
Measured: Up to 52 weeks
All-cause mortality through week 52
Measured: Up to 52 weeks
Incidence of Adverse events (AEs) and Adverse Events of Special Interest (AESIs)
AE = adverse event; AESI = adverse event of special interest
Measured: Up to 67 weeks
Incidence of Serious Adverse Events (SAEs)
SAE = Serious adverse event.
Measured: Up to 67 weeks
Serum concentrations of empasiprubart over time
Measured: Up to 52 weeks
Percentage Change From Baseline in Free Complement Component 2 (C2) Over Time
C2 = complement component 2
Measured: Up to 52 weeks
Percentage Change From Baseline in Total Complement Component 2 (C2) Over Time
C2 = complement component 2
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barré Syndrome (GBS)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821762
- Sponsor's protocol ID
- ARGX-117-29-GBS-2001
- Other IDs
- 2026-527247-17-00
- Acronym
- embridge
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Efficacy and Safety of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT07821762
- Acronym / sponsor ID
- embridge / ARGX-117-29-GBS-2001
- Conditions
- Guillain-Barré Syndrome (GBS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 16 Sep 2026 (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 main purpose of this study is to learn whether empasiprubart, when given in addition to intravenous immunoglobulin (IVIg), helps adults with Guillain-Barré syndrome (GBS) recover and whether it is safe. About 63 participants will be assigned by chance to receive either empasiprubart or placebo by intravenous infusion; all participants will also receive IVIg. The study includes screening for up to 72 hours, study treatment for the first two weeks, and follow-up through Week 67 (15 months after the last dose of study treatment). Participation lasts up to 67 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empasiprubart + IVIg | Experimental | Biological: Empasiprubart IV, Biological: Intravenous immunoglobulin (IVIg)Participants receive empasiprubart by intravenous infusion and IVIg by intravenous infusion. |
| Placebo + IVIg | Placebo comparator | Other: Empasiprubart Placebo IV, Biological: Intravenous immunoglobulin (IVIg)Participants receive placebo by intravenous and IVIg by intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria
- GBS-related weakness beginning within 7 days before the first study treatment
- GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline
- Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms
- Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown.
Key exclusion criteria (5 listed)
- History of a previous GBS episode or diagnosis of an atypical GBS variant
- Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency
- Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk
- IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe
- Recent treatment with IVIg except for a single IVIg dose administered during screening and within 24 hours before the first investigational medicinal product (IMP) dose for the current GBS episode or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies
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 |
|---|---|---|
| Empasiprubart IVIntravenous infusion of Empasiprubart | Biological | Empasiprubart + IVIg |
| Empasiprubart Placebo IVIntravenous infusion of Placebo | Other | Placebo + IVIg |
| Intravenous immunoglobulin (IVIg)Intravenous infusion of IVIg | Biological | Empasiprubart + IVIg, Placebo + IVIg |
Primary outcome
Proportion of Participants With a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2 at Week 4
Time frame: at week 4
The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability. It has 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability. A GBS-DS score ≤2 indicates the participant is able to walk 10 meters or more without assistance.
22 secondary outcomes
Number of calendar days in the intensive care unit (ICU) within the first 4 weeks of investigational medicinal product (IMP) administration
Time frame: Up to 4 weeks
Number of calendar days receiving invasive mechanical ventilation within the first 4 weeks of investigational medicinal product (IMP) administration
Time frame: Up to 4 weeks
Time From First Investigational Medicinal Product (IMP) Administration to Achieving a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2
Time frame: Up to 52 weeks
Actual values in the Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores at weeks 13 and 26
Time frame: Up to 26 weeks
Actual values in the Overall Neuropathy Limitations Scale (ONLS) Score at weeks 13 and 26
Time frame: Up to 26 weeks
Change from baseline in the Medical Research Council Sum Score (MRC-SS) over time
Time frame: Up to 52 weeks
Change from baseline in the Medical Research Council Sum Score (MRC-SS) neck flexion assessment over time
Time frame: Up to 52 weeks
Change from baseline in the Guillain-Barré Syndrome Disability Scale (GBS-DS) score over time
Time frame: Up to 52 weeks
Actual Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores Over Time
Time frame: Up to 52 weeks
Actual Overall Neuropathy Limitations Scale (ONLS) Score Over Time
Time frame: Up to 52 weeks
Number of calendar days receiving invasive mechanical ventilation through week 52
Time frame: Up to 52 weeks
Proportion of participants who require invasive mechanical ventilation over time and at any time through the week 52
Time frame: Up to 52 weeks
Number of calendar days in the Intensive Care Unit (ICU) through week 52
Time frame: Up to 52 weeks
Proportion of participants in the Intensive Care Unit (ICU) over time and at any time through week 52
Time frame: Up to 52 weeks
Number of calendar days from the start of investigational medicinal product (IMP) until discharge from the acute care facility/department
Time frame: Up to 52 weeks
Number of calendar days from the start of investigational medicinal product (IMP) until discharge from the last rehabilitation unit
Time frame: Up to 52 weeks
All-cause mortality through week 52
Time frame: Up to 52 weeks
Incidence of Adverse events (AEs) and Adverse Events of Special Interest (AESIs)
Time frame: Up to 67 weeks
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 67 weeks
Serum concentrations of empasiprubart over time
Time frame: Up to 52 weeks
Percentage Change From Baseline in Free Complement Component 2 (C2) Over Time
Time frame: Up to 52 weeks
Percentage Change From Baseline in Total Complement Component 2 (C2) Over Time
Time frame: Up to 52 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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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 study testing Empasiprubart IV and Intravenous immunoglobulin (IVIg) in people with Guillain-Barré Syndrome (GBS), run by argenx.
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 5 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 28 Oct 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Sabine Coppieters, MD (857-350-4834, ClinicalTrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2 at Week 4 (time frame: at week 4). 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 28 Oct 2026.