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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)
Novo Nordisk Clinical Trial Call Center
Lake Success, New York, United States
Observed adverse events
Time frame: From day -28 to day 113
Number of adverse Events (including injection site reactions)
Time frame: Every visit through study completion (Day 113)
Pharmacokinetics: terminal half-life, trough values, serum concentrations
Time frame: Day 1 through Day 113
Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
Time frame: 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)
Time frame: Day 1 through Day 113
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