NCT07020819 An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
| NCT ID | NCT07020819 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Annexon, Inc. |
| Condition | Guillain-Barre Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2025-09-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.
Eligibility Criteria
Key Inclusion Criteria: * Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS. * Onset of GBS-related weakness ≤10 days before start of infusion on Day 1 * GBS-disability score (DS) score of 3, 4, or 5 at screening and before start of infusion on Day 1. Key Exclusion Criteria: * Previous or intended treatment with either plasma exchange or IV immunoglobulin for GBS. * Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes. Other protocol-defined criteria may apply.
Contact & Investigator
Clinical Trials
STUDY DIRECTOR
Annexon, Inc.
Frequently Asked Questions
Who can join the NCT07020819 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 85 Years, studying Guillain-Barre Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07020819 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT07020819 currently recruiting?
Yes, NCT07020819 is actively recruiting participants. Contact the research team at clinicaltrials@annexonbio.com for enrollment information.
Where is the NCT07020819 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Carlsbad, United States, Orange, United States and 9 additional locations.
Who is sponsoring the NCT07020819 clinical trial?
NCT07020819 is sponsored by Annexon, Inc.. The principal investigator is Clinical Trials at Annexon, Inc.. The trial plans to enroll 30 participants.