Overview

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

Status:
Terminated
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
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