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Efavaleukin alfa
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Ensayo de AMGEN INC en Colitis ulcerosa.
Más ensayos de: Colitis ulcerosa.
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 221
- Centros
- 200
- Fin del objetivo primario
- oct 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en ene 2022.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.».
Qué mide
Percentage of Participants With Clinical Remission at Week 12 (del registro, en inglés) (semana 12)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
Más ensayos de AMGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Inebilizumab | Fase 3 | En marcha, sin reclutar | abr 2024 (real) |
| inebilizumab · MINT | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
| Tarlatamab · DeLLphi-304 | Fase 3 | En marcha, sin reclutar | ene 2025 (real) |
| Tarlatamab · DeLLphi-307 | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Maridebart Cafraglutide | Fase 2 | En marcha, sin reclutar | oct 2025 (real) |
| Erenumab Dose 1 · OASIS(EM) | Fase 3 | En marcha, sin reclutar | nov 2025 (real) |
Todos los de AMGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04987307), actualizada en dic 2025.