drugset / Trial / NCT07821762
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empasiprubart | Monoclonal antibody | — | Intravenous |
| Background | Intravenous immunoglobulin | Protein / enzyme biologic | — | Intravenous |