A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
Purpose
This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.
Condition
- Guillain-Barré Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open label combination treatment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Open Label Treatment Arm |
One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days. |
|
More Details
- Status
- Completed
- Sponsor
- Annexon, Inc.
Study Contact
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.