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

• Status: Withdrawn
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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