Calendario›REGN›Pozelimab
Pozelimab
Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy
Ensayo de REGENERON PHARMACEUTICALS, INC. en Hemoglobinuria paroxistica nocturna.
Más ensayos de: Hemoglobinuria paroxística nocturna.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 24
- Centros
- 13
- Fin del objetivo primario
- oct 2022
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2021.
Qué mide
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Through Week 28) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the safety and tolerability of 2 dosing regimens of pozelimab and cemdisiran combination therapy during the open-label treatment period (OLTP) The secondary objectives of the study are: * To evaluate the effect of the combination treatment on the following parameters of intravascular hemolysis: lactate dehydrogenase (LDH) control, breakthrough hemolysis, and inhibition of total complement hemolysis activity (CH50) * To evaluate the effect of the combination treatment on hemoglobin levels * To evaluate the effect of the combination treatment on red blood cell (RBC) transfusion requirements * To evaluate the effect of the combination treatment on clinical outcome assessments (COAs) measuring fatigue and health related quality of life * To assess the concentrations of total pozelimab in serum and total complement component (C) 5 and cemdisiran in plasma * To assess immunogenicity to pozelimab and cemdisiran * To evaluate the long-term safety and efficacy of pozelimab and cemdisiran in an optional open-label extension period (OLEP) * To assess safety after treatment intensification with pozelimab and cemdisiran
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 (NCT04811716), actualizada en abr 2025.