Clinical Trial

FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)

Active, Not Recruiting Phase 3
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Summary
The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).
Protocol Amendment History 41 amendments
This ClinicalTrials.gov record has been amended 41 times since 2021-02-22; most recent amendment 2026-07-18.
Status change: Recruiting → Active, Not Recruiting 2025-08-11
Status change: Not Yet Recruiting → Recruiting 2021-04-06
Trial Details
NCT Number NCT04768972
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Amyotrophic Lateral Sclerosis
Enrollment 89 participants
Start Date 2021-06-14
Primary Completion 2026-06-17 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-21