Status:
COMPLETED
A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
Lead Sponsor:
Annexon, Inc.
Collaborating Sponsors:
ResearchPoint Global
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Guillain-Barré Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 le...
Eligibility Criteria
Inclusion
- Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome
- Onset of GBS-related weakness ≤14 days prior to infusion
- GBS-DS score of 3, 4, or 5
Exclusion
- Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data
- Be at risk of suicide or self-harm
- Received previous treatment with plasma exchange for GBS
- Any diagnosis of a variant of GBS
- Have a history of anaphylaxis or severe systemic response to immunoglobulin
- Documented, clinically significant, pre-existing polyneuropathy from another cause
- Clinically significant intercurrent illness, medical condition, or medical history
- History of chronic use of steroid or immunosuppressant medication
- Active alcohol, drug, or substance abuse
- Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study
Key Trial Info
Start Date :
January 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04035135
Start Date
January 29 2020
End Date
May 19 2021
Last Update
August 11 2021
Active Locations (2)
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1
National Institute of Neurosciences and Hospital
Dhaka, Bangladesh
2
Aarhus University Hospital
Aarhus, Denmark