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

NCT ID: NCT04035135

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-29
• Study Completion Date: 2021-05-19

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ANX005

Intervention Type: DRUG

investigational drug

Intravenous immunoglobulin

Intervention Type: DRUG

investigational drug

Interventions

ANX005

investigational drug

Intervention Type: DRUG

Intravenous immunoglobulin

investigational drug

Intervention Type: DRUG

Other Intervention Names

Anti C1q Antibody; IVIg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResearchPoint Global

OTHER

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Annexon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henk-André Kroon, MD, MBA

Role: STUDY_DIRECTOR

Annexon, Inc.

Locations

National Institute of Neurosciences and Hospital

Dhaka, , Bangladesh

Aarhus University Hospital

Aarhus, , Denmark

Countries

Bangladesh; Denmark

Other Identifiers

ANX005-GBS-03

Identifier Type: -

Identifier Source: org_study_id