Clinical Trial

A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Study acronym: ARMOR
Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-12-04; most recent amendment 2026-07-02.
Status change: Not Yet Recruiting → Recruiting 2026-02-02
Trial Details
NCT Number NCT07290062
Lead Sponsor Insmed Gene Therapy LLC
Conditions Amyotrophic Lateral Sclerosis
Enrollment 23 participants
Start Date 2026-01-09
Primary Completion 2030-03-31 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-06