Trial Profile

Phase 1/2 Investigation of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (Pioneer-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002

Status: Not yet recruiting

Phase of Trial: Phase I/II

Latest Information Update: 23 Dec 2025

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At a glance

Drugs Methylprednisolone (Primary) ; Prednisone (Primary) ; VTx-002-VectorY-Therapeutics (Primary)
Indications Amyotrophic lateral sclerosis
Focus Adverse reactions
Acronyms ALS; PIONEER-ALS
Sponsors VectorY

19 Dec 2025 Status changed from planning to not yet recruiting.
03 Dec 2025 According to VectorY Therapeutics media release, James Berry Global Coordinating Investigator of the trial.
03 Dec 2025 According to VectorY Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared the company to proceed with the PIONEER-ALS Phase 1/2 Trial of VTx-002

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