HEALEY ALS Platform Trial - Regimen G DNL343
Phase 2/3
Completed
NCT05842941
| Condition | Amyotrophic Lateral Sclerosis |
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| Phase | Phase 2/3 |
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| Sponsor | Merit E. Cudkowicz, MD |
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| Status | Completed |
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| Enrollment | 249 participants |
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| Interventions | DNL343, Matching Placebo |
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| Start date | May 24, 2023 |
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| Completion date | Oct 29, 2024 |
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| Results posted | Jan 28, 2026 |
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Summary
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.
Disease Progression as Assessed by the ALSFRS-R-Slope
Baseline to 24 Weeks · Percent change
| DNL343 | -0.88 ± 0.062 Percent change |
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| Matching Placebo | -0.84 ± 0.081 Percent change |
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| Disease Rate Ratio | 1.06 (95% CI 0.840–1.351) |
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Mortality Event Rate
Baseline to 24 weeks · Events per month
| DNL343 | 0.007 ± 0.0021 Events per month |
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| Matching Placebo | 0.007 ± 0.0020 Events per month |
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Open in BENITIONS
View on ClinicalTrials.gov
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