Guillain-Barre SyndromePhase 3NCT04701164
Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
A Phase 3 study testing ANX005 in people with Guillain-Barre Syndrome, run by Annexon, Inc. at 11 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- ANX005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 17 Dec 2020to 20 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Philippines9 sites
Baguio General Hospital Medical Center
Baguio City
Batangas Medical Center
Batangas
Mary Mediatrix Medical Center
Batangas
Perpetual Succour Hospital
Cebu City
Cotabato Regional Medical Center
Cotabato City
Southern Philippines Medical Center
Davao City
Jose R. Reyes Memorial Medical Center
Manila
West Visayas State University Medical Center
Manila
Zamboanga City Medical Center
Zamboanga City
Bangladesh2 sites
Dhaka Medical Center
Dhaka
National Institute of Neurosciences and Hospital (NINS)
Dhaka
About this study
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
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.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- ANX005, Placebo
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX005Drug
Solution for intravenous infusion
PlaceboDrug
Solution for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ANX005 Treatment Group - Dose 1 | Experimental | Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1. Receives: Drug: ANX005 |
| ANX005 Treatment Group - Dose 2 | Experimental | Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1. Receives: Drug: ANX005 |
| Placebo Group | Placebo comparator | Participants will receive a single IV infusion of placebo on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GBS Disability Score (GBS-DS) at Week 8
Measured: Week 8
Number of Participants with Adverse Events
Number participants recently diagnosed with GBS who experience adverse events.
Measured: Through Month 6
Secondary outcomes (7)
Medical Research Council (MRC) Sum Score at Week 8
Measured: Week 8
MRC Sum Score at Day 8
Measured: Day 8
Duration (Days) of Ventilation Support Over 26 Weeks
Measured: 26 weeks
GBS Disability Score (GBS-DS)
Measured: Week 26
Number of Participants Requiring Intensive Care Unit Stay
Measured: 26 weeks
Duration (Days) of Intensive Care Unit Stays
Measured: 26 weeks
Patient Global Impression of Change Scores
Measured: Week 8 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start17 Dec 2020
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Annexon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701164
- Sponsor's protocol ID
- ANX005-GBS-02
- Status last verified
- May 2025
- First submitted
- 6 Jan 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04701164
- Acronym / sponsor ID
- ANX005-GBS-02
- Conditions
- Guillain-Barre Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANX005 Treatment Group - Dose 1 | Experimental | Drug: ANX005Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1. |
| ANX005 Treatment Group - Dose 2 | Experimental | Drug: ANX005Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of placebo on Day 1. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANX005Solution for intravenous infusion | Drug | ANX005 Treatment Group - Dose 1, ANX005 Treatment Group - Dose 2 |
| PlaceboSolution for intravenous infusion | Drug | Placebo Group |
Primary outcome
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.
7 secondary outcomes
Medical Research Council (MRC) Sum Score at Week 8
Time frame: Week 8
MRC Sum Score at Day 8
Time frame: Day 8
Duration (Days) of Ventilation Support Over 26 Weeks
Time frame: 26 weeks
GBS Disability Score (GBS-DS)
Time frame: Week 26
Number of Participants Requiring Intensive Care Unit Stay
Time frame: 26 weeks
Duration (Days) of Intensive Care Unit Stays
Time frame: 26 weeks
Patient Global Impression of Change Scores
Time frame: Week 8 and Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
Related trials for Guillain-Barre Syndrome
Recruiting
High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Critical Illness Myopathy, Guillain Barré Syndrome
Not yet recruitingPhase 2
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
Guillain-Barré Syndrome (GBS)
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Not yet recruitingObservational study
Peripheral Nerve Ultrasound in Children With Guillain-Barré Syndrome
Guillain-Barre Syndrome
RecruitingObservational study
Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome
Guillain Barre Syndrome, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Annexon, Inc.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ANX005 in people with Guillain-Barre Syndrome, run by Annexon, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Philippines, Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GBS Disability Score (GBS-DS) at Week 8 (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.