Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
Primary Purpose
Guillain-Barre Syndrome
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ANX005
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Guillain-Barre Syndrome
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 ≤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:
- Body weight >150 kg.
- Unresponsive nerve conduction study results in all nerves tested during screening.
- Previous or intended, future 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.
- Prior treatment with any monoclonal antibody.
- History of hypercoagulable diseases, hyper viscosity, thrombosis, or acute renal failure.
- Documented, clinically significant, pre-existing polyneuropathy from another cause.
- Females who are pregnant, breastfeeding, or unable or unwilling to use 2 methods of contraception throughout the study.
Sites / Locations
- Dhaka Medical CenterRecruiting
- National Institute of Neurosciences and Hospital (NINS)Recruiting
- Baguio General Hospital Medical CenterRecruiting
- Batangas Medical CenterRecruiting
- Mary Mediatrix Medical CenterRecruiting
- Perpetual Succour HospitalRecruiting
- Cotabato Regional Medical CenterRecruiting
- Southern Philippines Medical CenterRecruiting
- Jose R. Reyes Memorial Medical CenterRecruiting
- West Visayas State University Medical CenterRecruiting
- Zamboanga City Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ANX005 Treatment Group - Dose 1
ANX005 Treatment Group - Dose 2
Placebo Group
Arm Description
Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
Participants will receive a single IV infusion of placebo on Day 1.
Outcomes
Primary Outcome Measures
GBS Disability Score (GBS-DS) at Week 8
Number of Participants with Adverse Events
Number participants recently diagnosed with GBS who experience adverse events.
Secondary Outcome Measures
Medical Research Council (MRC) Sum Score at Week 8
MRC Sum Score at Day 8
Duration (Days) of Ventilation Support Over 26 Weeks
GBS Disability Score (GBS-DS)
Number of Participants Requiring Intensive Care Unit Stay
Duration (Days) of Intensive Care Unit Stays
Patient Global Impression of Change Scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04701164
Brief Title
Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Annexon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barre Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANX005 Treatment Group - Dose 1
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
Arm Title
ANX005 Treatment Group - Dose 2
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV infusion of placebo on Day 1.
Intervention Type
Drug
Intervention Name(s)
ANX005
Intervention Description
Solution for intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for intravenous infusion
Primary Outcome Measure Information:
Title
GBS Disability Score (GBS-DS) at Week 8
Time Frame
Week 8
Title
Number of Participants with Adverse Events
Description
Number participants recently diagnosed with GBS who experience adverse events.
Time Frame
Through Month 6
Secondary Outcome Measure Information:
Title
Medical Research Council (MRC) Sum Score at Week 8
Time Frame
Week 8
Title
MRC Sum Score at Day 8
Time Frame
Day 8
Title
Duration (Days) of Ventilation Support Over 26 Weeks
Time Frame
26 weeks
Title
GBS Disability Score (GBS-DS)
Time Frame
Week 26
Title
Number of Participants Requiring Intensive Care Unit Stay
Time Frame
26 weeks
Title
Duration (Days) of Intensive Care Unit Stays
Time Frame
26 weeks
Title
Patient Global Impression of Change Scores
Time Frame
Week 8 and Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 ≤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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Annexon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dhaka Medical Center
City
Dhaka
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhahirul Islam, MD
Facility Name
National Institute of Neurosciences and Hospital (NINS)
City
Dhaka
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhahirul Islam, MD
Facility Name
Baguio General Hospital Medical Center
City
Baguio
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Batangas Medical Center
City
Batangas
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Mary Mediatrix Medical Center
City
Batangas
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Perpetual Succour Hospital
City
Cebu City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Cotabato Regional Medical Center
City
Cotabato
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Southern Philippines Medical Center
City
Davao
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Jose R. Reyes Memorial Medical Center
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
West Visayas State University Medical Center
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
Facility Name
Zamboanga City Medical Center
City
Zamboanga
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-822-5500
Email
clinicaltrials@annexonbio.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
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