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REGN3918

Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Ensayo de REGENERON PHARMACEUTICALS, INC. en Paroxysmal Nocturnal Hemoglobinuria (PNH) (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

24

previstos

Centros

12

Fin del objetivo primario

jun 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2019.

Qué mide

Percentage of Participants Who Achieved Adequate Control of Intravascular Hemolysis (del registro, en inglés) (de la semana 4 a la semana 26)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patients with active PNH who are treatment-naive to complement inhibitor therapy or have not recently received complement inhibitor therapy. The secondary objectives of the study are: * To evaluate the safety and tolerability of REGN3918. * To evaluate the effect of REGN3918 on parameters of intravascular hemolysis * To assess the concentrations of total REGN3918 in serum. * To evaluate the incidence of treatment-emergent anti-drug antibodies to REGN3918 over time * To evaluate the effect of REGN3918 on patient-reported outcomes (PROs) measuring fatigue and health-related quality of life

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03946748), actualizada en jun 2023.