An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

Phase 1TerminatedNCT01689025

Novo Nordisk A/S10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammation Systemic Lupus Erythematosus

Interventions

NNC0114-0006DRUG

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

placeboDRUG

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (5)

Novo Nordisk Clinical Trial Call Center

La Jolla, California, United States

Novo Nordisk Clinical Trial Call Center

Houston, Texas, United States

Unnamed facility

Szeged, Hungary

Unnamed facility

Poznan, Poland

Unnamed facility

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: From first administration of the trial product and up to week 26

Secondary Outcomes

PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)

Time frame: After the last dosing (Week 6)

PK endpoint from serum NNC0114-0006: Accumulation based on the concentration

Time frame: 2 weeks after the first (week 2) and the last dose (week 8)

Change in serum levels of total IL-21 (Interleukin-21)

Time frame: Week 0, week 26

Change in disease activity (SELENA-SLEDAI)

Time frame: Week 0, week 12

Change in corticosteroid usage

Time frame: Week 0, week 12

Data from ClinicalTrials.gov

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