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Cemdisiran · ACCESS 2

Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

Ensayo de REGENERON PHARMACEUTICALS, INC. en Hemoglobinuria paroxistica nocturna.

Más ensayos de: Hemoglobinuria paroxística nocturna.

Fase

Fase 3

Estado

Interrumpido

Participantes

3

previstos

Centros

1

Fin del objetivo primario

jul 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision not related to efficacy or safety.».

Qué mide

Percent Change in Lactate Dehydrogenase (LDH) From Baseline to Week 36 (From baseline to week 36) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is: To evaluate the effect of pozelimab and cemdisiran combination therapy on hemolysis, as assessed by lactate dehydrogenase (LDH), after 36 weeks of treatment, in patients with PNH who switch from eculizumab or ravulizumab therapy versus patients who continue their eculizumab or ravulizumab therapy The secondary objectives of the study are to: * Evaluate the effect of pozelimab and cemdisiran combination treatment versus anti-C5 standard-of-care treatment (eculizumab or ravulizumab) on the following: * Transfusion requirements and transfusion parameters * Measures of hemolysis: LDH control, breakthrough hemolysis, and inhibition of CH50 * Hemoglobin levels * Fatigue as assessed by Clinical Outcome Assessments (COAs) * Health-related quality of life (HRQoL) as assessed by COAs * Safety and tolerability * To assess the concentrations of total pozelimab and either total eculizumab or total ravulizumab in serum and total cemdisiran and total C5 protein in plasma * To assess the immunogenicity of pozelimab and cemdisiran

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05131204), actualizada en abr 2025.