drugset / Trial / NCT05494619
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)
Phase 3
Withdrawn
Hoffmann-La Roche
Chugai Pharmaceutical Co., Ltd. (Sponsor in Taiwan and Japan) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab compared with placebo as an add-on therapy to intravenous immunoglobulin (IVIg) in participants with severe GBS.
Timeline
- Start
- 2022-11-30
- Primary completion
- 2026-03-19
- Completion
- 2026-09-30
Outcome
Outcome not reported
Stopped: “This study has been withdrawn due to an internal decision. The decision was not due to any safety concerns with study drug.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crovalimab | Monoclonal antibody | 340 mg | Intravenous |
| Background | Intravenous immunoglobulin | Protein / enzyme biologic | 400 mg/kg | Intravenous |