A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome

NCT07821762 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ARGX-117-29-GBS-20012026-527247-17-00
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Guillain-Barré Syndrome (GBS)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 4 weeks

• Number of calendar days receiving invasive mechanical ventilation within the first 4 weeks of investigational medicinal product (IMP) administration

  Up to 4 weeks

• Time From First Investigational Medicinal Product (IMP) Administration to Achieving a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2

  Up to 52 weeks

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

  Up to 26 weeks

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

  Up to 26 weeks

Study Arms (2)

Empasiprubart + IVIg

EXPERIMENTAL

Participants receive empasiprubart by intravenous infusion and IVIg by intravenous infusion.

Biological: Empasiprubart IV; Biological: Intravenous immunoglobulin (IVIg)

Placebo + IVIg

PLACEBO COMPARATOR

Participants receive placebo by intravenous and IVIg by intravenous infusion.

Other: Empasiprubart Placebo IV; Biological: Intravenous immunoglobulin (IVIg)

Interventions

Empasiprubart IV BIOLOGICAL

Intravenous infusion of Empasiprubart

Empasiprubart + IVIg

Empasiprubart Placebo IV OTHER

Intravenous infusion of Placebo

Placebo + IVIg

Intravenous immunoglobulin (IVIg) BIOLOGICAL

Intravenous infusion of IVIg

Empasiprubart + IVIg; Placebo + IVIg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; ClinicalTrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share