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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Inflammation, Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT01689025

Run by

Novo Nordisk A/S

People needed

10

Starts

2012-09-01

Expected to finish

2014-02-01

Last updated by the study team

2014-04-08

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Clinical Trial Call Center — La Jolla, California, United States
• Novo Nordisk Clinical Trial Call Center — Houston, Texas, United States
• Study site — Szeged, Hungary
• Study site — Poznan, Poland
• Study site — Belgrade, Serbia

Full record on ClinicalTrials.gov

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