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

Phase 1

Withdrawn

• Conditions: Inflammation; Systemic Lupus Erythematosus
• Interventions: Drug: NNC 0151-0000-0000; Drug: placebo

• Registration Number: NCT01018238
• Lead Sponsor: Novo Nordisk A/S

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Status Verified: 2014-07
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3	NNC 0151-0000-0000	-
Cohort 1	NNC 0151-0000-0000	-
Placebo arm	placebo	-
Cohort 2	NNC 0151-0000-0000	-
Cohort 4	NNC 0151-0000-0000	-

Primary Outcome Measures

Name	Time	Method
Observed adverse events	From day -28 to day 113

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Lake Success, New York, United States