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Open-Label Envudeucitinib · ONWARD3
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Ensayo de ALUMIS INC. en Psoriasis en placas · Psoriasis (PsO) · Psoriasis · Psoriasis moderada · Psoriasis severa.
Más ensayos de: Psoriasis en placas · Psoriasis.
- Fase
- Fase 3
- Estado
- En marcha, sin reclutar
- Participantes
- 1.680
- Centros
- 268
- Fin del objetivo primario
- nov 2028
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2025.
Qué mide
Evaluar la seguridad y tolerabilidad a largo plazo de ESK-001 durante la duracion del estudio (unos 4 años)
Qué se prueba
El estudio evalúa la seguridad y la eficacia de ESK-001 a largo plazo en personas con psoriasis en placas de moderada a grave.
Lo que dice el documentoHow safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks.
Traducción automática (claude-sonnet-5), con la cita comprobada contra el documento y revisada por una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.
Más ensayos de ALMS
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Envudeucitinib · LUMUS | Fase 2 | En marcha, sin reclutar | jun 2026 (real) |
| envudeucitinib | Fase 2 | En marcha, sin reclutar | dic 2027 (prevista) |
| envudeucitinib | Fase 1 | Completado | mar 2026 (real) |
| Envudeucitinib · ONWARD2 | Fase 3 | Completado | sep 2025 (real) |
| Envudeucitinib · ONWARD1 | Fase 3 | Completado | sep 2025 (real) |
| ESK-001 | Fase 1 | Completado | ago 2025 (real) |
Todos los de ALMS, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06846541), actualizada en abr 2026.