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Monoclonal Antibodies

ANX005 for ALS

Phase 2
Recruiting
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 day 1 and week 24
Awards & highlights

Study Summary

This trial is testing a new drug for ALS. The drug will be given intravenously (through the vein) to people with ALS. The trial is open-label, meaning that everyone will know what drug they are receiving.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Secondary outcome measures
Area Under the ANX005 Serum Concentration-Time Curve
Change from Baseline in Free Complement (C) 1q Serum Concentrations
Maximum Observed Serum Concentration (Cmax) of ANX005
+1 more
Other outcome measures
Pharmacodynamics (PD) effects of ANX005

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
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Annexon, Inc.Lead Sponsor
12 Previous Clinical Trials
774 Total Patients Enrolled
Lahar Mehta, MDStudy DirectorAnnexon, Inc.
1 Previous Clinical Trials
600 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
600 Patients Enrolled for Amyotrophic Lateral Sclerosis
Benjamin Hoehn, MDStudy DirectorAnnexon, Inc.
2 Previous Clinical Trials
131 Total Patients Enrolled

Media Library

ANX005 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04569435 — Phase 2
Amyotrophic Lateral Sclerosis Research Study Groups: ANX005
Amyotrophic Lateral Sclerosis Clinical Trial 2023: ANX005 Highlights & Side Effects. Trial Name: NCT04569435 — Phase 2
ANX005 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569435 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively taking part in this clinical experiment?

"To satisfy the requirements of this study, 24 participants that fit into the qualifying criteria must be identified. Annexon Inc., is responsible for carrying out the trial in multiple locations, including UCSF in San Francisco and the Annexon Investigational Site 12 located in Calgary, Alberta."

Answered by AI

Does this trial still have availability for participants?

"This clinical trial is actively recruiting as per information disseminated on clinicaltrials.gov, with the first posting occurring on January 15th 2021 and a recent edit taking place on July 1st 2022."

Answered by AI

Is ANX005 deemed a secure treatment for people?

"Based on the evidence available, there is a moderate level of safety associated with ANX005. As this medication has only reached Phase 2 trials so far, efficacy data has yet to be collected."

Answered by AI

How numerous are the health care facilities that have embraced this trial?

"14 medical centres are currently hosting this research study, including ones in Calgary, San Francisco and New york. To reduce need for travel, participants would benefit from selecting the closest clinic to them when enrolling."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California, Irvine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
2021. "Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04569435.
All > Lou Gehrigs Disease > Als
~6 spots leftby Apr 2025
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