What side effects are associated with this type of intervention?

Common treatments for ALS include riluzole, edaravone, and various investigational drugs. Riluzole can cause side effects such as nausea, weakness, and liver function abnormalities. Edaravone may lead to bruising, gait disturbances, and allergic reactions. Investigational treatments like GM604 and masitinib have shown potential side effects including injection site reactions and gastrointestinal issues. While specific side effects of C1q inhibition (like ANX005) are not detailed, similar treatments often involve immune modulation, which can lead to increased infection risk and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Amyotrophic Lateral Sclerosis (ALS), including riluzole and edaravone. Riluzole is believed to reduce damage to motor neurons by decreasing the release of glutamate, while edaravone is thought to act as an antioxidant, reducing oxidative stress. Other investigational treatments include masitinib, a tyrosine kinase inhibitor, and various stem cell therapies. While specific FDA-approved treatments targeting C1q inhibition, like ANX005, are not mentioned, the ongoing research and trials indicate a continuous effort to explore new therapeutic avenues for ALS.

What other types of research exist?

Promising novel alternatives to ANX005 for ALS patients include Tofersen, an antisense oligonucleotide targeting SOD1 mutations, and Reldesemtiv, a fast skeletal muscle troponin activator. Additionally, AMX0035, a combination of sodium phenylbutyrate and taurursodiol, has shown potential in clinical trials. These therapies represent cutting-edge approaches targeting different aspects of ALS pathogenesis.

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Monoclonal Antibodies

ANX005 for ALS

Phase 2

Waitlist Available

Research Sponsored by Annexon, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ANX005, an IV medication, in people with ALS to see if it can help manage or slow down their symptoms.

Who is the study for?

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.

What is being tested?

The study tests ANX005 administered through an IV in people with ALS. It's an open-label trial, meaning both researchers and participants know what treatment is being given, conducted across multiple centers.

What are the potential side effects?

While specific side effects are not listed here, typical IV medication risks include pain at the injection site, infection risk from needles, allergic reactions to the drug components, and possible unforeseen effects on motor neuron disease symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Pharmacodynamics (PD) effects of ANX005

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ANX005Experimental Treatment1 Intervention

Participants will receive induction dosing of ANX005 on Days 1 and 5 or 6, followed by maintenance doses of ANX005 every 2 weeks up to Week 22.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ANX005

2021

Completed Phase 3

~310

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Amyotrophic Lateral Sclerosis (ALS) include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol. Riluzole works by inhibiting glutamate release, which may reduce excitotoxicity that leads to motor neuron death. Edaravone acts as an antioxidant, reducing oxidative stress that contributes to neuronal damage. Sodium phenylbutyrate-taurursodiol combines two compounds that reduce neuronal cell death by targeting different cellular stress pathways. C1q inhibition, such as with ANX005, aims to prevent the activation of the complement system, which is involved in neuroinflammation and may contribute to motor neuron degeneration. These treatments are crucial for ALS patients as they target different mechanisms of neuronal damage, potentially slowing disease progression and improving quality of life.