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

This study has been terminated.
(See detailed description)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01018238
First received: November 16, 2009
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Inflammation
Systemic Lupus Erythematosus
Drug: NNC 0151-0000-0000
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Observed adverse events [ Time Frame: From day -28 to day 113 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse Events (including injection site reactions) [ Time Frame: Every visit through study completion (Day 113) ] [ Designated as safety issue: No ]
  • Pharmacokinetics: terminal half-life, trough values, serum concentrations [ Time Frame: Day 1 through Day 113 ] [ Designated as safety issue: No ]
  • Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies [ Time Frame: Day 1 through Day 113 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: November 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo arm Drug: placebo
Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)
Experimental: Cohort 1 Drug: NNC 0151-0000-0000
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
Experimental: Cohort 2 Drug: NNC 0151-0000-0000
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
Experimental: Cohort 3 Drug: NNC 0151-0000-0000
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
Experimental: Cohort 4 Drug: NNC 0151-0000-0000
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018238

Locations
United States, New York
Novo Nordisk Clinical Trial Call Center
Lake Success, New York, United States, 11042-1008
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Christine O'Brien, BS Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01018238     History of Changes
Other Study ID Numbers: NN8209-3608, U1111-1112-1881
Study First Received: November 16, 2009
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Lupus Erythematosus, Systemic
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 20, 2014