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An open label clinical study to evaluate ANX005 (also known as tanruprubart) in participants with Guillain-Barré syndrome (FORWARD Study)
EU CTIS ID: 2025-522664-32-00
What this study is testing
To characterize the PK profile of a single dose of ANX005 30 mg/kg in participants recently diagnosed with GBS from North America and Europe
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female aged 12 through 85 years at the time of signing the informed consent/assent
- Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke (NINDS) Diagnostic Criteria for GBS
- Onset of GBS-related weakness ≤10 days before infusion on Day 1
- GBS-DS score of 3, 4, or 5 at Screening and before infusion on Day 1
- If female at birth, must either be postmenopausal (no menses for ≥12 months without an alternative medical cause) or surgically sterilized; OR if of childbearing potential, use an acceptable method of contraception (Appendix 2) during the study and for at least 30 days after infusion with study drug
- Agree not to use drugs of abuse during participation in the study and to undergo drug testing at Screening and at any time point during the study if drug abuse is suspected
You likely can't join if
- Clinically significant findings on the Screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS and that may interfere with the conduct of the study, the interpretation of the data, or increase risk to the participant
- Significant allergies to humanized monoclonal antibodies
- History of a prior episode of GBS
- Clinically significant uncontrolled intercurrent illness not associated with GBS that in the Investigator’s judgement could compromise the safety of the participant or interpretation of the data derived from the participant
- History of autoimmune disorder (eg, rheumatoid arthritis, systemic lupus erythematosus)
- Active meningitis, septicemia, or sepsis at Screening
See the full eligibility criteria
Who can join
- Male or female aged 12 through 85 years at the time of signing the informed consent/assent
- Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke (NINDS) Diagnostic Criteria for GBS
- Onset of GBS-related weakness ≤10 days before infusion on Day 1
- GBS-DS score of 3, 4, or 5 at Screening and before infusion on Day 1
- If female at birth, must either be postmenopausal (no menses for ≥12 months without an alternative medical cause) or surgically sterilized; OR if of childbearing potential, use an acceptable method of contraception (Appendix 2) during the study and for at least 30 days after infusion with study drug
- Agree not to use drugs of abuse during participation in the study and to undergo drug testing at Screening and at any time point during the study if drug abuse is suspected
- Able to comply with the requirements of the study and complete the full sequence of protocol-related procedures and evaluations, including after hospitalization and at outpatient follow-up visits
- Able to understand and provide written informed consent/assent (participant or participant’s legal representative/guardian)
What rules you out
- Clinically significant findings on the Screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS and that may interfere with the conduct of the study, the interpretation of the data, or increase risk to the participant
- Significant allergies to humanized monoclonal antibodies
- History of a prior episode of GBS
- Clinically significant uncontrolled intercurrent illness not associated with GBS that in the Investigator’s judgement could compromise the safety of the participant or interpretation of the data derived from the participant
- History of autoimmune disorder (eg, rheumatoid arthritis, systemic lupus erythematosus)
- Active meningitis, septicemia, or sepsis at Screening
- Chronic use of corticosteroids (ie, >20 mg/day prednisone or equivalent) within 30 days before infusion on Day 1
- Any known genetic deficiencies of the complement cascade system
- Treatment with an unapproved investigational therapeutic agent within 30 days (or 5 half-lives for small molecule agents) before infusion on Day 1
- Active alcohol or drug abuse, or any other reason that makes it unlikely that the participant will comply with study procedures. Participants with positive test results for 1 or more substances of abuse are not eligible to participate in the study.
- Any participant who is pregnant (positive pregnancy test at Screening) or breastfeeding
- At risk of suicide or self-harm in the opinion of the Investigator
- Any participant expected to require immediate treatment with IVIg or PE based on status at presentation and/or likelihood for rapid deterioration per the mEGOS or risk for respiratory failure per the modified Erasmus GBS Respiratory Insufficiency Score (mEGRIS).
- Body weight <30 or >150 kg at Screening
- Unresponsive (inexcitable) nerve conduction study results in all nerves tested during Screening
- Previous or planned treatment with either PE or IVIg within 90 days of Day 1. Note: Rescue treatment is allowed per protocol.
- Current diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff’s encephalitis, or overlap syndromes
- Documented, clinically significant, pre-existing polyneuropathy from another cause (eg, diabetes mellitus [except mild sensory], alcoholism, severe vitamin deficiency, porphyria)
- History of previous infusion reactions (ie, sensitivities or allergic or anaphylactic reactions to previous medication infusions)
- Hypersensitivity to ANX005 or any of the excipients in the ANX005 drug product
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.