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

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

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.

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