Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome

Guillain-Barre Syndrome Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects With Guillain-Barré Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701164
• Other study ID #: ANX005-GBS-02
• Status: Recruiting
• Phase: Phase 3
• Start date: December 17, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2023
• Source: Annexon, Inc.
• Contact: Study Coordinator
• Phone: 650-822-5500
• Email: clinicaltrials[@]annexonbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 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 =10 days prior to start of infusion.
• GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion.

Exclusion Criteria:

• Clinically significant findings on the screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS that may interfere with the conduct of the study, the interpretation of the data, or increase the participant's risk.
• Body weight <30 kilograms (kg) or >150 kg at screening.
• Unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening.
• Previous or intended treatment with either plasma exchange or intravenous immunoglobulin for GBS.
• Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
• History of prior episode of GBS.
• GBS-related weakness that improved since symptom onset, including an improvement between screening and Day 1 (baseline).

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Syndrome

Intervention

Drug:
• ANX005
Solution for intravenous infusion
• Placebo
Solution for intravenous infusion

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical Center	Dhaka
Bangladesh	National Institute of Neurosciences and Hospital (NINS)	Dhaka
Philippines	Baguio General Hospital Medical Center	Baguio
Philippines	Batangas Medical Center	Batangas
Philippines	Mary Mediatrix Medical Center	Batangas
Philippines	Perpetual Succour Hospital	Cebu City
Philippines	Cotabato Regional Medical Center	Cotabato
Philippines	Southern Philippines Medical Center	Davao
Philippines	Jose R. Reyes Memorial Medical Center	Manila
Philippines	West Visayas State University Medical Center	Manila
Philippines	Zamboanga City Medical Center	Zamboanga

Sponsors (1)

Lead Sponsor	Collaborator
Annexon, Inc.

Countries where clinical trial is conducted

Bangladesh,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GBS Disability Score (GBS-DS) at Week 8		Week 8
Primary	Number of Participants with Adverse Events	Number participants recently diagnosed with GBS who experience adverse events.	Through Month 6
Secondary	Medical Research Council (MRC) Sum Score at Week 8		Week 8
Secondary	MRC Sum Score at Day 8		Day 8
Secondary	Duration (Days) of Ventilation Support Over 26 Weeks		26 weeks
Secondary	GBS Disability Score (GBS-DS)		Week 26
Secondary	Number of Participants Requiring Intensive Care Unit Stay		26 weeks
Secondary	Duration (Days) of Intensive Care Unit Stays		26 weeks
Secondary	Patient Global Impression of Change Scores		Week 8 and Week 26