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BIIB105 · ALSpire

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

Ensayo de BIOGEN INC. en Esclerosis lateral amiotrofica.

Más ensayos de: Esclerosis lateral amiotrófica.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

99

previstos

Centros

17

Fin del objetivo primario

ago 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2020.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor's decision».

Qué mide

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (From first dose of the study drug in Part 1 up to end of follow up period in Part 1 (up to Day 260)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04494256), actualizada en sep 2025.