Purpose

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

Condition

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

ArmDescriptionAssigned 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.
  • Drug: ANX005
    investigational drug
    Other names:
    • Anti C1q Antibody
  • Drug: Intravenous immunoglobulin
    investigational drug
    Other names:
    • IVIg

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.