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3K3A-APC in ALS
NCT05039268Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2021
- Primary completion
- Sep 2022
- Countries
- 1
- Sponsor
- Macquarie University
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- 3K3A-APC
- Conditions
- amyotrophic lateral sclerosis (ALS)
01
Overview
Phase 2, open-label trial of 3K3A-APC in amyotrophic lateral sclerosis (ALS) (2 arms), sponsored by Macquarie University. Primary endpoints: Number of Participants Who Had Any Serious Adverse Events or Any Adverse Events With Severity Higher Than Moderate at 15 Days and Percentage of Change in PERSI Score in the Motor Cortex Before and After Dosing at 7 Days. Started Nov 2021; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
15mg Dose Group
3K3A-APC 15mg IV every 12 hours for 5 doses
30mg Dose Group
3K3A-APC 30mg IV every 12 hours for 5 doses
03
Who it enrols
Patients with clinically definite ALS (Awaji Criteria), symptom onset < 36 months, and diagnosis < 24 months. Excludes patients on anticoagulants or with bleeding risks.
04
Endpoints
Primary
Number of Participants Who Had Any Serious Adverse Events or Any Adverse Events With Severity Higher Than Moderate
Percentage of Change in PERSI Score in the Motor Cortex Before and After Dosing
Secondary
Diffusion Kurtosis Using MRI Scan
Monocyte Activation
Cytokine Level
Chemokine Level
Neurofilament Level
Soluble CD14 Level
Kynurenine Level
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