Calendario›REGN›Ravulizumab · ACCESS-1
Ravulizumab · ACCESS-1
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
Ensayo de REGENERON PHARMACEUTICALS, INC. en Hemoglobinuria paroxistica nocturna.
Más ensayos de: Hemoglobinuria paroxística nocturna.
- Fase
- Fase 3
- Estado
- En marcha, sin reclutar
- Participantes
- 202
- Centros
- 68
- Fin del objetivo primario
- oct 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2022.
Qué mide
Cambio porcentual en la lactato deshidrogenasa (LDH) (From baseline to week 26) (del registro, en inglés)
Qué se prueba
Se estudia la combinacion de pozelimab y cemdisiran en personas con hemoglobinuria paroxistica nocturna (PNH), comparandola con los tratamientos ya existentes ravulizumab y eculizumab.
Lo que dice el documentoThis study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs".
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Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: * How effective is the pozelimab + cemdisiran combination compared to ravulizumab? * How effective is pozelimab + cemdisiran combination compared to eculizumab? * What side effects may happen from taking the study drugs? * How much study drugs are in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)
Más ensayos de REGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| cemiplimab | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Pozelimab + Cemdisiran · NIMBLE | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Garetosmab · OPTIMA | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Aflibercept 8 mg · ELARA | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Dupilumab · ENGAGE | Fase 2 | En marcha, sin reclutar | feb 2026 (real) |
| Fianlimab | Fase 3 | En marcha, sin reclutar | mar 2026 (real) |
Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05133531), actualizada en abr 2026.