Calendario›BIIB›BG00011 · SPIRIT
BG00011 · SPIRIT
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
Ensayo de BIOGEN INC. en Fibrosis pulmonar idiopatica.
Más ensayos de: Fibrosis pulmonar idiopática.
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 109
- Centros
- 90
- Fin del objetivo primario
- nov 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2018.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study was stopped because of safety concerns.».
Qué mide
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 (del registro, en inglés) (inicio y semana 52)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.
Más ensayos de BIIB
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Diranersen · CELIA | Fase 2 | En marcha, sin reclutar | mar 2026 (real) |
| BIIB142 | Fase 1 | Reclutando pacientes | ago 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · TOPAZ-2 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · TOPAZ-1 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · AMETHYST | Fase 2/3 | En marcha, sin reclutar | oct 2026 (prevista) |
| Natalizumab | no aplica | En marcha, sin reclutar | oct 2026 (prevista) |
Todos los de BIIB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03573505), actualizada en dic 2020.