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NCT Number: NCT07821762

A Study 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 through Day 12, and follow-up through Week 67 (15 months after the last dose of study treatment). Participation lasts up to 67 weeks.

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Key information

Conditions

Guillain-Barré Syndrome (GBS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old
  • 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.

Exclusion criteria

  • 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 or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies

Treatment and study plan

Empasiprubart IV

Biological

Intravenous infusion of Empasiprubart

Empasiprubart Placebo IV

Other

Intravenous infusion of Placebo

Intravenous immunoglobulin (IVIG)

Biological

Intravenous infusion of IVIg

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    ICU means intensive care unit; IMP means investigational medicinal product

  2. 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

    IMP means investigational medicinal product

  3. 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

    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.

  4. Actual values in the Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores at weeks 13 and 26

    Time frame: Up to 26 weeks

    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.

  5. Actual values in the Overall Neuropathy Limitations Scale (ONLS) Score at weeks 13 and 26

    Time frame: Up to 26 weeks

    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.

  6. Change from baseline in the Medical Research Council Sum Score (MRC-SS) over time

    Time frame: Up to 52 weeks

    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 is used to evaluate the severity of weakness and changes in motor function over time, with higher scores reflecting greater muscle strength.

  7. Change from baseline in the Medical Research Council Sum Score (MRC-SS) neck flexion assessment over time

    Time frame: Up to 52 weeks

    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).

  8. Change from baseline in the Guillain-Barré Syndrome Disability Scale (GBS-DS) score over time

    Time frame: Up to 52 weeks

    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.

  9. Actual Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores Over Time

    Time frame: Up to 52 weeks

    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.

  10. Actual Overall Neuropathy Limitations Scale (ONLS) Score Over Time

    Time frame: Up to 52 weeks

    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.

  11. Number of calendar days receiving invasive mechanical ventilation through week 52

    Time frame: Up to 52 weeks

  12. Proportion of participants who require invasive mechanical ventilation over time and at any time through the week 52

    Time frame: Up to 52 weeks

  13. Number of calendar days in the Intensive Care Unit (ICU) through week 52

    Time frame: Up to 52 weeks

    ICU means intensive care unit.

  14. Proportion of participants in the Intensive Care Unit (ICU) over time and at any time through week 52

    Time frame: Up to 52 weeks

    ICU means intensive care unit.

  15. 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

    IMP means investigational medicinal product

  16. 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

    IMP means investigational medicinal product

  17. All-cause mortality through week 52

    Time frame: Up to 52 weeks

  18. Incidence of Adverse events (AEs) and Adverse Events of Special Interest (AESIs)

    Time frame: Up to 67 weeks

    AE = adverse event; AESI = adverse event of special interest

  19. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 67 weeks

    SAE = Serious adverse event.

  20. Serum concentrations of empasiprubart over time

    Time frame: Up to 52 weeks

  21. Percentage Change From Baseline in Free Complement Component 2 (C2) Over Time

    Time frame: Up to 52 weeks

    C2 = complement component 2

  22. Percentage Change From Baseline in Total Complement Component 2 (C2) Over Time

    Time frame: Up to 52 weeks

    C2 = complement component 2

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study 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

Acronym: embridge

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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