A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT02437890Tipo: INTERVENTIONALInicio: 1 de jul de 2015Fin estimado: 1 de ene de 2018

Traducción no disponible, mostrando original

Resumen

Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 64 YearsSexo: ALL

Criterios de inclusión

Man or woman ≥ 18 years and \< 65 years of age
Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997 American College of Rheumatology (ACR) or 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
Have moderate to severe active SLE
Have seropositive disease at screening
Subject must be at least on one or more of the treatments for SLE as listed in the protocol
Others as defined in the protocol

Criterios de exclusión

Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at baseline for the organ systems that can be clinically assessed
Have a systemic inflammatory disease other than SLE
Clinically significant infection treated or needing treatment
Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study
Have received prior therapy blocking the interleukin-6 (IL-6) pathway
Others as defined in the protocol

Intervenciones

biological

ALX-0061

biological

Placebo

Ubicaciones

Investigator Site

Caba, Buenos Aires, Argentina

Investigator Site

Caba, Argentina

Investigator Site

Ciudad Autónoma de Buenos Aire, Argentina

Investigator Site

Córdoba, Argentina

Investigator Site

San Juan, Argentina

Investigator Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalAblynx, a Sanofi company

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