NCT04768972Phase 3Active not recruiting

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)

Study sponsor: Ionis Pharmaceuticals, Inc. · IONS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-06-17Actual

Enrollment · participants89Actual

Source updated2026-07-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-21 · 2 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Jun 2026~~

+ After

17 Jun 2026

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Study details

Conditions studied

Amyotrophic Lateral Sclerosis

Treatments or interventions studied

ION363Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change from Baseline (Day 1) through Study Day 505 in Part 1 in functional impairment; description: Functional impairment to be measured by joint rank analysis of the combined assessment of: In-clinic Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score, time of rescue or discontinuation from Part 1 and entering Part 2 due to a deterioration in function, and ventilation assistance-free survival (VAFS). ALSFRS-R measures functional disease severity. The scale measures four functional domains, bulbar function, gross motor skills, fine motor skills, and respiratory function. The assessment will contain 12 questions scored from 0 (no function) to 4 (full function), with a total possible score of 48, which will indicate the highest level of function. ALSFRS-R will be a part of the combined assessment of joint rank analysis to assess efficacy in Part 1.; timeFrame: Baseline, Day 505 in Part 1

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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