NCT05053035

A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Alector Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 2 double-blind, placebo-controlled study of AL001 in participants with C9orf72-associated ALS.

Detailed description

This is a phase 2 double-blind, placebo-controlled trial to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 in participants with C9orf72-associated Amyotrophic Lateral Sclerosis.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	AL001	Administered via intravenous (IV) infusion
DRUG	Placebo	Administered via intravenous (IV) infusion

Timeline

• Start date: 2021-09-02
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2021-09-22
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study