ANX005 for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called ANX005 for people with ALS, a condition affecting nerve cells in the brain and spinal cord. The goal is to determine if ANX005, administered through an IV, can slow the progression of ALS symptoms. Eligible participants should have an ALS diagnosis with weakness starting within the past three years. Participants will receive doses every few weeks for about 22 weeks. Those who frequently visit doctors for ALS and meet these criteria might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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 ANX005 is likely to be safe for humans?
Research has shown that ANX005 has been tested for safety and effectiveness in individuals with conditions such as Guillain-Barré syndrome and ALS. One study found that participants receiving ANX005 were 2.4 times more likely to experience health improvements compared to those who did not receive it, suggesting the treatment's potential promise.
However, ANX005 remains in Phase 2 trials for ALS, meaning detailed safety information is still being gathered. Phase 2 trials typically indicate that the treatment was safe in early studies, but researchers are now examining its effects and any potential side effects in a larger group.
If ANX005 is considered for ALS, it has likely been well-tolerated in earlier studies. Nonetheless, participants must be aware of possible risks and discuss them with their healthcare provider.12345Why do researchers think this study treatment might be promising for ALS?
Researchers are excited about ANX005 for ALS because it offers a new approach by targeting the complement system, which plays a role in inflammation and nerve damage in ALS. Unlike standard treatments like riluzole and edaravone, ANX005 is designed to prevent the progression of nerve cell damage by inhibiting specific complement proteins. This targeted mechanism could potentially slow down the disease's progression more effectively than current options, bringing hope for improved outcomes in ALS patients.
What evidence suggests that ANX005 might be an effective treatment for ALS?
Research suggests that ANX005, which participants in this trial will receive, may help treat ALS, a disease affecting the nerves. Earlier studies found that ANX005 could slow the disease's progression in patients. It blocks certain proteins that might cause nerve damage in ALS. Although more research is needed, these early results offer hope for its potential to manage ALS symptoms.13678
Who Is on the Research Team?
Benjamin Hoehn, MD, PhD
Principal Investigator
Annexon, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with ALS who have experienced muscle weakness within the last 3 years and have a certain level of lung function. Participants must be vaccinated against specific bacteria or willing to get vaccinated, use effective contraception if of childbearing potential, and not weigh over 150 kilograms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive induction dosing of ANX005 on Days 1 and 5 or 6, followed by maintenance doses every 2 weeks up to Week 22
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants will be contacted by phone 6 months after study completion
What Are the Treatments Tested in This Trial?
Interventions
- ANX005
Find a Clinic Near You
Who Is Running the Clinical Trial?
Annexon, Inc.
Lead Sponsor