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An Investigation of of NNC 0152-0000-0001 in Patients With Systemic Lupus Erythematosus (SLE) - NCT00960362-10021(Clinical Trial 306071)



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City:  New York
State:  
NY
Zip Code: 10021
Conditions: Inflammation - Systemic Lupus Erythematosus (SLE)
Purpose: This trial is conducted in Europe and North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses and repeated doses of NNC 0152-0000-0001 in patients with systemic lupus erythematosus (SLE).
Study summary:
Criteria: Inclusion Criteria: - Diagnosis of SLE - Disease duration longer or equal to 6 months - Stable, mild to moderate active 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 dosing - Active vasculitis requiring treatment - Body weight over 120 kg - History of cancer - Infections - viral: 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 (TB) - Severe systemic microbial infections within the past 12 months prior to dosing - Immunosuppressive and immune modulating therapy
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Data Source: ClinicalTrials.gov
Date Processed: June 7, 2010
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