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

Guillain-Barré Syndrome Clinical Trial

Official title:

A Phase 1b Study to Evaluate the Safety, Tolerability and Drug-Drug Interactions of ANX005 and Intravenous Immunoglobulin (IVIg) in Subjects With Guillain Barré Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035135
• Other study ID #: ANX005-GBS-03
• Status: Completed
• Phase: Phase 1
• Start date: January 29, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: August 2021
• Source: Annexon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Guillain-Barré Syndrome
• Syndrome

Intervention

Drug:
• ANX005
investigational drug
• Intravenous immunoglobulin
investigational drug

Locations

Country	Name	City	State
Bangladesh	National Institute of Neurosciences and Hospital	Dhaka
Denmark	Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
Annexon, Inc.	International Centre for Diarrhoeal Disease Research, Bangladesh, ResearchPoint Global

Countries where clinical trial is conducted

Bangladesh,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics of ANX005 when administered in combination with IVIg	As measured by ANX005 serum concentrations	3 months
Secondary	Pharmacodynamics of ANX005 when administered in combination with IVIg	As measured by CH50 and C1q serum concentrations	4 months
Secondary	Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit	The 6-point Guillain-Barré Syndrme Disability Score (GBS-DS) is a widely accepted and easily obtainable scoring system used to assess functional status of GBS subjects. The score is as follows: 0 = Healthy, 1 = Minor symptoms and capable of running, 2 = Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4 = Bedridden or chair bound, 5 = Needing mechanical ventilation, 6 = death	6 months