A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
The ALSpire Study is a clinical trial evaluating the investigational drug BIIB105 in adults living with amyotrophic lateral sclerosis (ALS). The ALSpire Study consists of two parts: * Part 1: 6-month placebo-controlled study. During Part 1, participants are randomly assigned to receive either BIIB105 or placebo in a 3:1 or 2:1 ratio (depending on the participant's assigned Cohort). * Part 2: up to 3-year long-term open-label extension. During Part 2, all participants receive BIIB105. The objectives of the study are to evaluate: * The safety and tolerability of BIIB105 in people with ALS * What the body does to BIIB105 (also called "pharmacokinetics") * What BIIB105 does to the body (also called "pharmacodynamics") * Whether BIIB105 can slow the worsening of clinical function
Key facts
- Study ID
- NCT04494256
- Run by
- Biogen
- People needed
- 99
- Starts
- 2020-09-28
- Expected to finish
- 2024-08-13
- Last updated by the study team
- 2025-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- University of California San Diego Medical Center — La Jolla, California, United States
- Stanford Neuromuscular Research Center — Palo Alto, California, United States
- University of Colorado Hospital - Neuroscience Center -Anschutz Medical Campus — Aurora, Colorado, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- Mayo Clinic Florida — Jacksonville, Florida, United States
- Orlando Health — Orlando, Florida, United States
- The Emory Clinic — Atlanta, Georgia, United States
- ALS Clinic - Department of Neurology, Neuromuscular Division, Johns Hopkins University, School of Medicine — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Washington University, School of Medicine — St Louis, Missouri, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Houston Methodist Neurological Institute — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Montreal Neurological Institute-Hospital — Montreal, Quebec, Canada
- A.O.U. Città della salute e della scienza di Torino — Torino, Italy
- UMC Utrecht — Utrecht, Netherlands
Full record on ClinicalTrials.gov
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