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IMU-838 · EMPhASIS
MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)
Ensayo de IMMUNIC, INC. en Relapsing-Remitting Multiple Sclerosis (RRMS) (del registro, en inglés).
- Fase
- Fase 2
- Estado
- En marcha, sin reclutar
- Participantes
- 210
- Centros
- 38
- Fin del objetivo primario
- abr 2020
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2019.
Qué mide
Difference Between 45 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions (del registro, en inglés) (hasta la semana 24)
Qué se prueba
Se prueban dos dosis diarias orales de IMU-838 (vidofludimus calcium) frente a placebo en pacientes con RRMS con enfermedad activa, en un ensayo de fase 2.
Lo que dice el documentoThis is a Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), 30 mg/day and 45 mg/day in the main study, cohort 1 (and 10 mg/day for the patients in the cohort 2 substudy), in patients with RRMS and evidence of active disease.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), 30 mg/day and 45 mg/day in the main study, cohort 1 (and 10 mg/day for the patients in the cohort 2 substudy), in patients with RRMS and evidence of active disease. The trial consists of a screening period, a blinded 24-week main treatment period, and an optional initially blinded, then open-label extended treatment period of up to 9.5 years. About 40 centers are planned to participate in Romania, Bulgaria, Ukraine, and Poland; potential additional centers in Hungary and Croatia were not used. The study started with 195 patients in the main group (cohort 1) planned to be randomized 1:1:1 to treatment with 30 mg/day or 45 mg/day IMU-838, or placebo (65 patients each) in the main treatment period. During the extended treatment period, patients were initially re-randomized so that patients previously on placebo were re-randomized 1:1 to treatment with 30 g/day or 45 mg/day IMU-838, all other patients were re-randomized to the same treatment they previously received. With approval of Protocol Version 3.0, a sub-study patient group (cohort 2) has been added with up to 60 patients, randomized to placebo or 10 mg IMU-838 for 24 weeks after which the option is available to continue into the extended treatment period and the recommended dose of 30 mg/day. However, based on discussion between investigator and patient 45 mg/day IMU-838/day may also be used.
Más ensayos de IMUX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| IMU-838 tablets · ENSURE-2 | Fase 3 | En marcha, sin reclutar | nov 2026 (prevista) |
| IMU-838 tablets · ENSURE-1 | Fase 3 | En marcha, sin reclutar | nov 2026 (prevista) |
| IMU-838 · CALLIPER | Fase 2 | Sin noticias del promotor | ene 2025 (prevista, ya pasada: sin actualizar en el registro) |
| IMU-935 | Fase 1 | Interrumpido | may 2023 (real) |
| IMU-838 · CALDOSE-1 | Fase 2 | Interrumpido | nov 2022 (real) |
| IMU-838 | Fase 2/3 | Completado | ene 2021 (real) |
Todos los de IMUX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03846219), actualizada en abr 2024.