drugset / Trial / NCT07821762

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

NCT07821762 ↗

Phase 2 Not yet recruiting 63 enrolled argenx
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-12
Primary completion
2028-01
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Empasiprubart Monoclonal antibody — Intravenous
Background Intravenous immunoglobulin Protein / enzyme biologic — Intravenous