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Fasinumab · FACT CLBP 1

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Ensayo de REGENERON PHARMACEUTICALS, INC. en Chronic Low Back Pain · Osteoarthritis (del registro, en inglés).

Más ensayos de: Artrosis.

Fase

Fase 3

Estado

Interrumpido

Participantes

63

previstos

Centros

56

Fin del objetivo primario

may 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2017.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to implementation of an urgent safety measure, enrollment and dosing in R475-PN-1612 was stopped; enrolled participants entered the 20-week safety follow-up».

Qué mide

Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score (del registro, en inglés) (semana 1, semana 2, semana 4, semana 8, semana 12, semana 16)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03285646), actualizada en jun 2021.