NCT04701164CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Annexon, Inc.
- Enrollment
- 242
- Locations
- 11
- Primary Endpoint
- GBS Disability Score (GBS-DS) at Week 8
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Placebo Group
Placebo Comparator
Participants will receive a single IV infusion of placebo on Day 1.
Intervention: Placebo (Drug)
ANX005 Treatment Group - Dose 2
Experimental
Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
Intervention: ANX005 (Drug)
ANX005 Treatment Group - Dose 1
Experimental
Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
Intervention: ANX005 (Drug)
Outcomes
Primary Outcomes
GBS Disability Score (GBS-DS) at Week 8
Time Frame: Week 8
Number of Participants with Adverse Events
Time Frame: Through Month 6
Number participants recently diagnosed with GBS who experience adverse events.
Secondary Outcomes
- Medical Research Council (MRC) Sum Score at Week 8(Week 8)
- MRC Sum Score at Day 8(Day 8)
- Duration (Days) of Ventilation Support Over 26 Weeks(26 weeks)
- GBS Disability Score (GBS-DS)(Week 26)
- Number of Participants Requiring Intensive Care Unit Stay(26 weeks)
- Duration (Days) of Intensive Care Unit Stays(26 weeks)
- Patient Global Impression of Change Scores(Week 8 and Week 26)
Investigators
Study Sites (11)
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