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

August 14, 2014 updated by: Novo Nordisk A/S

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)

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11042-1008
        • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Observed adverse events
Time Frame: From day -28 to day 113
From day -28 to day 113

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse Events (including injection site reactions)
Time Frame: Every visit through study completion (Day 113)
Every visit through study completion (Day 113)
Pharmacokinetics: terminal half-life, trough values, serum concentrations
Time Frame: Day 1 through Day 113
Day 1 through Day 113
Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
Time Frame: Day 1 through Day 113
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)
Time Frame: Day 1 through Day 113
Day 1 through Day 113

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (ESTIMATE)

November 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8209-3608
  • U1111-1112-1881 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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