NCT04035135

A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)

A Phase 1b Study to Evaluate the Safety, Tolerability and Drug-Drug Interactions of ANX005 and Intravenous Immunoglobulin (IVIg) in Subjects With Guillain Barré Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.

Detailed description

The study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of ANX005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with IVIg. Dosing of IVIg will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and ANX005 will be administered concurrently, beginning on Day 1 or 2 of the treatment period. Subjects will be followed for 6 months after treatment for observation and evaluation.

Conditions

• Guillain-Barré Syndrome

Interventions

Type	Name	Description
DRUG	ANX005	investigational drug
DRUG	Intravenous immunoglobulin	investigational drug

Timeline

• Start date: 2020-01-29
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2019-07-29
• Last updated: 2021-08-11

Locations

2 sites across 2 countries: Bangladesh, Denmark

Regulatory

• FDA-regulated drug study