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ANX005 for ALS (Amyotrophic Lateral Sclerosis)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
ALS (Amyotrophic Lateral Sclerosis)ANX005 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

7 Primary · 5 Secondary · Reporting Duration: Blood samples collected predose to Day 5/6 after end of infusion on Day 1 and to EOS after Week 12 visit

Week 36
Change from Baseline in Free Complement (C) 1q Serum Concentrations
Week 12
Pharmacokinetic: AUC(0-inf)
Pharmacokinetic: AUC(0-t)
Pharmacokinetic: Cmax
Week 12
Pharmacodynamic: C1q inhibition in CSF
Week 10
Pharmacokinetics (PK) of ANX005
Week 24
Area Under the ANX005 Serum Concentration-Time Curve
Maximum Observed Serum Concentration (Cmax) of ANX005
Up to Week 36
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Serum
Up to week 12
Incidence of treatment emergent adverse events (Safety and Tolerability) of ANX005
Safety: Number of Participants Who Experienced Treatment-Emergent Adverse Events
up to Week 24
Pharmacodynamics (PD) effects of ANX005

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
[11C]MPC6827
1
Vermont RETAIN
1
CNS10-NPC-GDNF

Trial Design

1 Treatment Group

ANX005
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: ANX005 · No Placebo Group · Phase 2

ANX005
Drug
Experimental Group · 1 Intervention: ANX005 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ANX005
2020
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: blood samples collected predose to day 5/6 after end of infusion on day 1 and to eos after week 12 visit

Who is running the clinical trial?

Annexon, Inc.Lead Sponsor
11 Previous Clinical Trials
737 Total Patients Enrolled
Benjamin Hoehn, MD, PhDStudy DirectorAnnexon, Inc.
Lahar Mehta, MDStudy DirectorAnnexon, Inc.
1 Previous Clinical Trials
600 Total Patients Enrolled
Benjamin Hoehn, MDStudy DirectorAnnexon, Inc.
2 Previous Clinical Trials
131 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male and you have a female partner of childbearing potential.
You are willing to undergo vaccinations.
References

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