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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)

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NCT04768972

Sponsored by Ionis Pharmaceuticals, Inc. (industry) · IONS — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
89actual
Sites
25
Countries
Belgium, Brazil, Canada +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-06-14actualWhen the study began enrolling
Primary completion2026-06-17actualThe date the last participant is measured for the primary outcome — the readout window
Study completionMar 2028estimatedThe whole study's end, after follow-up
First posted2021-02-24actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-21actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Amyotrophic Lateral Sclerosis

Interventions

  • Drug: ION363
  • Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF
Change from Baseline (Day 1) through Study Day 505 in Part 1 in functional impairment
measured Baseline, Day 505 in Part 1

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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