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

Annexon

Status and phase: Completed; Phase 1

Conditions: Guillain-Barré Syndrome

Treatments: Drug: ANX005; Drug: Intravenous immunoglobulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04035135

ANX005-GBS-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Open Label Treatment Arm

Experimental group

Description:

One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days.

Treatment:

Drug: Intravenous immunoglobulin

Drug: ANX005