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Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, PK and PD of Antisense Oligonucleotide AMX0114 Administered to Adult Participants With Amyotrophic Lateral Sclerosis

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Trial Profile

Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, PK and PD of Antisense Oligonucleotide AMX0114 Administered to Adult Participants With Amyotrophic Lateral Sclerosis

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 15 Jun 2025

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At a glance

  • Drugs AMX 0114 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus First in man; Therapeutic Use
  • Acronyms LUMINA
  • Sponsors Amylyx Pharmaceuticals

Most Recent Events

  • 08 Jun 2025 Planned End Date changed from 1 Dec 2027 to 1 Oct 2027.
  • 08 Jun 2025 Planned primary completion date changed from 1 Jul 2027 to 1 Feb 2027.
  • 03 Jun 2025 According to an Amylyx Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the treatment of people living with amyotrophic lateral sclerosis (ALS).

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