临床试验/NCT01689025

NCT01689025终止1 期

A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2012年9月最近更新: 2014年4月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Novo Nordisk A/S
入组人数: 10
试验地点: 1
主要终点: Incidence of Adverse Events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and women (not pregnant and not nursing)
•Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
•Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
•If taken, background medication must be stable

排除标准

•Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
•Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2

研究组 & 干预措施

NNC0114-0006

Experimental

干预措施: NNC0114-0006 (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Incidence of Adverse Events (AEs)

时间窗: From first administration of the trial product and up to week 26

次要结局

Change in serum levels of total IL-21 (Interleukin-21)(Week 0, week 26)
Change in disease activity (SELENA-SLEDAI)(Week 0, week 12)
Change in corticosteroid usage(Week 0, week 12)
PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)(After the last dosing (Week 6))
PK endpoint from serum NNC0114-0006: Accumulation based on the concentration(2 weeks after the first (week 2) and the last dose (week 8))

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

2 期

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's DiseaseInflammationCrohn's Disease

NCT01751152Novo Nordisk A/S53

终止

2 期

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MethotrexateInflammationRheumatoid Arthritis

NCT01636843Novo Nordisk A/S298

终止

2 期

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa BiologicsInflammationRheumatoid Arthritis

NCT01636817Novo Nordisk A/S239

已完成

1 期

Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary BypassAcquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary Bypass

NCT02239146Novo Nordisk A/S43

已完成

3 期

A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1

NCT01999322Novo Nordisk A/S37