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REGN2477+REGN1033

Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis

Ensayo de REGENERON PHARMACEUTICALS, INC. en Sporadic Inclusion Body Myositis (del registro, en inglés).

Fase

Fase 2

Estado

Retirado antes de empezar

Fin del objetivo primario

ago 2020

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2019.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was withdrawn due to an internal decision».

Qué mide

Percent change in total lean mass as measured by dual-energy X-ray absorptiometry (DXA) (del registro, en inglés) (hasta la semana 20)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the efficacy of REGN2477+REGN1033 in combination on total lean mass, as measured by Dual-energy X-ray absorptiometry (DXA) in patients with sporadic inclusion body myositis (sIBM). The secondary objectives of the study are: * To evaluate the efficacy of REGN2477+REGN1033 on the IBM-Functional Rating Scale (IBM-FRS) * To evaluate the efficacy of REGN2477+REGN1033 on the sIBM Physical Functioning Assessment (sIFA) * To evaluate the safety and tolerability of REGN2477+REGN1033 * To evaluate the effects of REGN2477+REGN1033 on body composition by DXA, including appendicular lean mass and total fat mass * To evaluate the efficacy of REGN2477+REGN1033 on measures of muscle performance and physical function * To evaluate the efficacy of REGN2477+REGN1033 on patient reported outcome measures including the fear of falling, falls and near falls, and health-related quality of life * To evaluate the pharmacokinetic(s) (PK) profile of REGN2477+REGN1033, including functional REGN2477 and functional REGN1033 concentrations in serum over time * To evaluate the immunogenicity of REGN2477+REGN1033

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03710941), actualizada en abr 2019.