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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04701164
Other study ID # ANX005-GBS-02
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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