An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Inflammation, Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT01018238

Run by

Novo Nordisk A/S

People needed

0

Starts

2009-11-01

Expected to finish

2009-11-01

Last updated by the study team

2014-08-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Clinical Trial Call Center — Lake Success, New York, United States

Full record on ClinicalTrials.gov

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