A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT04433585Tipo: INTERVENTIONALInicio: 19 de ago de 2020Fin estimado: 16 de feb de 2023

Traducción no disponible, mostrando original

Resumen

The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).

Descripción detallada

LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
Have a clinical SLEDAI-2K score ≥4 at randomization.
Have active arthritis and/or active rash.

Criterios de exclusión

Have severe active lupus nephritis.
Have active central nervous system (CNS) lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.

Intervenciones

drug

LY3471851

Administered SC

drug

Placebo

Administered SC

Ubicaciones

DOM- Centro de Reumatologia

CABA, Buenos Aires, Argentina

Centro Privado de Medicina Familiar / Mindout Research

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

APRILLUS Asistencia E Investigacion de Arcis Salud

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

Hospital J. M. Ramos Mejía

Ciudad Autónoma de Buenos Aire, Argentina

Hospital Córdoba

Córdoba, Argentina

Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

San Juan, Argentina

Patrocinadores

PrincipalNektar Therapeutics

ColaboradorEli Lilly and Company

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