ANX005 for ALS

Recruiting at 16 trial locations

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Annexon, Inc.

Disqualifiers: Intercurrent illness, Weight > 150kg, ANA titer ≥ 1:160, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 22 weeks

17 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

Research Team

Benjamin Hoehn, MD, PhD

Principal Investigator

Annexon, Inc.

Eligibility Criteria

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

If female, must be postmenopausal, surgically sterilized, or agree to use highly effective methods of contraception from Screening through Week 36

You have experienced weakness within the last 3 years before the start of the study.

Your lung function test shows that you can breathe out at least 50% of what is expected based on your age, height, and sex while sitting.

Exclusion Criteria

Clinically significant, ongoing or intercurrent illness, medical condition, or medical history that would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the safety data derived from the participant

You have a high level of antinuclear antibodies in your blood.

You weigh more than 150 kilograms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Long-term follow-up

Participants will be contacted by phone 6 months after study completion

Treatment Details

Interventions

• ANX005

Trial Overview 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.

Participant Groups

Group I: ANX005 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Annexon, Inc.

Lead Sponsor

Trials

14

Recruited

1,500+