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

NCT04035135 | Completed Phase 1 FDA Drug

• 1 other identifier: ANX005-GBS-03
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Guillain-Barré Syndrome

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's

  As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation.

  6 months

Secondary Outcomes (3)

• Pharmacokinetics of ANX005 when administered in combination with IVIg

  3 months

• Pharmacodynamics of ANX005 when administered in combination with IVIg

  4 months

• Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit

  6 months

Study Arms (1)

Open Label Treatment Arm

EXPERIMENTAL

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; Drug: Intravenous immunoglobulin

Interventions

ANX005 DRUG

investigational drug

Also known as: Anti C1q Antibody

Open Label Treatment Arm

Intravenous immunoglobulin DRUG

investigational drug

Also known as: IVIg

Open Label Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Annexon, Inc.: lead
• ResearchPoint Global: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (2)

National Institute of Neurosciences and Hospital

Dhaka, Bangladesh

Location

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Henk-André Kroon, MD, MBA

  Annexon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label combination treatment

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 29, 2019
• Study Start: January 29, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1); DK (1)