Inflammation, Systemic Lupus Erythematosus
Conditions
Brief summary
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).
Detailed description
The trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.
Interventions
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
DRUGplacebo
Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of systemic lupus erythematosus (SLE) * Disease duration: 6 months or longer * Stable, mild to moderately active systemic lupus erythematosus (SLE) * Receiving stable maintenance therapy
Exclusion criteria
* Significant Lupus Nephritis * Active central nervous system (CNS) disease * Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start * Body weight of 260 lbs/120 kg or more * History of alcohol or substance abuse * History of cancer * Infections * Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2) * Tuberculosis * Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start * Immunosuppressive and immune modulating therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed adverse events | From day -28 to day 113 |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse Events (including injection site reactions) | Every visit through study completion (Day 113) |
| Pharmacokinetics: terminal half-life, trough values, serum concentrations | Day 1 through Day 113 |
| Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies | Day 1 through Day 113 |
| Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL) | Day 1 through Day 113 |
Countries
United States
Outcome results
None listed