An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
| Status: | Completed |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 11/30/2013 |
| Start Date: | September 2012 |
| End Date: | January 2015 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
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
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