Tanruprubart for Guillain-Barré Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called tanruprubart for individuals with Guillain-Barré Syndrome (GBS), a condition where the immune system attacks the nerves, causing muscle weakness. The researchers aim to understand how the body processes the drug, its impact on the disease, and its safety. Participants will receive a single dose of this experimental treatment to assess its early effectiveness. Individuals diagnosed with GBS who began experiencing weakness within the last 10 days may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that tanruprubart is likely to be safe for humans?
Research shows that tanruprubart is being tested for its safety in treating Guillain-Barré Syndrome. One study administered a single dose of 30 mg/kg of tanruprubart to patients. The results were promising, with patients spending less time on ventilators, suggesting the treatment might be well-tolerated.
Although detailed safety information remains limited, the current phase of the study indicates that tanruprubart met certain safety standards in earlier trials. This means it is considered safe enough for testing on more people. However, like any new treatment, some risks may still exist. It's important to discuss possible side effects with a doctor before deciding to join a trial.12345Why do researchers think this study treatment might be promising?
Tanruprubart is unique because it offers a new approach to treating Guillain-Barré Syndrome (GBS) with a single 30 mg/kg intravenous infusion. Unlike current treatments like intravenous immunoglobulin (IVIG) and plasmapheresis, which can require multiple sessions and longer durations to take effect, tanruprubart aims to streamline the process by delivering a potent dose all at once. Researchers are excited about this treatment because it has the potential to work faster and more efficiently, potentially improving recovery times for patients with GBS.
What evidence suggests that tanruprubart might be an effective treatment for Guillain-Barré Syndrome?
Research has shown that tanruprubart may help treat Guillain-Barré Syndrome (GBS). In earlier studies, patients who took tanruprubart were about three times more likely to improve than those who received standard treatments like IVIg or PE. After eight weeks, 29% of patients on tanruprubart had low disability scores, compared to 12% in the placebo group. The treatment also significantly reduced the time patients needed ventilators, which is crucial for those with severe symptoms. These findings suggest that tanruprubart could be a promising option for improving health outcomes in GBS patients. Participants in this trial will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.34678
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Annexon, Inc.
Are You a Good Fit for This Trial?
This trial is for adults and children in the US, Canada, and Europe with Guillain-Barré Syndrome (GBS) as per specific diagnostic criteria. Participants must have a GBS-disability score of 3 to 5 and onset of weakness within 10 days before treatment starts.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tanruprubart
Trial Overview
The study tests Tanruprubart's effects on pharmacokinetics (how the body processes the drug), pharmacodynamics (how the drug affects the body), early efficacy (how well it works initially), and safety in treating GBS.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Annexon, Inc.
Lead Sponsor
Citations
1.
ir.annexonbio.com
ir.annexonbio.com/news-releases/news-release-details/annexon-showcases-tanruprubart-data-demonstrating-improvedAnnexon Showcases Tanruprubart Data Demonstrating ...
Patients treated with tanruprubart were approximately three times more likely to be in a better state of health than patients on IVIg or PE on ...
New insights in the immune treatment of Guillain–Barré ...
Despite being well tolerated and significantly reducing serum C5 concentration, eculizumab did not demonstrate improvements in functional outcomes compared to ...
Targeted Treatment Improves Disability in Guillain-Barre ...
At week 8, 29% of patients treated with 30 mg/kg of tanruprubart scored 0 to 1 on the GBS-DS compared with 12% in the placebo group. Similarly, ...
219 Tanruprubart (ANX005) Targeted Therapy Reduces ...
These results demonstrate that tanruprubart significantly reduces ventilation duration in patients with GBS, even those already ventilated at treatment ...
5.
finance.yahoo.com
finance.yahoo.com/news/annexon-showcases-tanruprubart-data-demonstrating-200500182.htmlAnnexon Showcases Tanruprubart Data Demonstrating ...
Annexon Showcases Tanruprubart Data Demonstrating Improved Clinical Outcomes in Guillain-Barré Syndrome (GBS) at 2025 Peripheral Nerve Society ( ...
NCT07020819 | An Open Label Clinical Study to Evaluate ...
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study).
7.
ir.annexonbio.com
ir.annexonbio.com/news-releases/news-release-details/annexon-highlights-pivotal-data-first-potential-targeted-therapyAnnexon Highlights Pivotal Data on First Potential Targeted ...
The primary endpoint, GBS-Disability Scale (DS), showed that after a single infusion of tanruprubart at 30 mg/kg dose, patients had a ...
Annexon Showcases Tanruprubart Data Demonstrating ...
Annexon Showcases Tanruprubart Data Demonstrating Improved Clinical Outcomes in Guillain-Barré Syndrome (GBS) at 2025 Peripheral Nerve Society ( ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.