Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amyotrophic Lateral Sclerosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: ANX005 administered for up to 12 weeksMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
In this Phase 2a, multi-center, open label, proof-of-biology study of ANX005 will be administered to up to approximately 24 subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 12 weeks. Induction Dose: Each subject will receive induction dosing of ANX005 on Days 1 and 5 or 6 (5/6). Maintenan...
In this Phase 2a, multi-center, open label, proof-of-biology study of ANX005 will be administered to up to approximately 24 subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 12 weeks. Induction Dose: Each subject will receive induction dosing of ANX005 on Days 1 and 5 or 6 (5/6). Maintenance Dose: Each subject will receive a maintenance dose of ANX005 every 2 weeks (Weeks 2, 4, 6, 8, and 10). Maintenance doses are expected to be completed over approximately 4-5 hours. Follow-up visits will be on Weeks 12, 16, and 24. All subjects will be contacted by phone 6 months after study completion.
Tracking Information
- NCT #
- NCT04569435
- Collaborators
- Worldwide Clinical Trials
- Investigators
- Not Provided
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