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NOT YET RECRUITING
NCT07821762
PHASE2

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

Sponsor: argenx

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-12

Completion Date

2029-03

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

Empasiprubart IV

Intravenous infusion of Empasiprubart

OTHER

Empasiprubart Placebo IV

Intravenous infusion of Placebo

BIOLOGICAL

Intravenous immunoglobulin (IVIg)

Intravenous infusion of IVIg