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

Primary Purpose

Inflammation, Systemic Lupus Erythematosus

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC 0151-0000-0000
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo arm

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Outcomes

Primary Outcome Measures

Observed adverse events

Secondary Outcome Measures

Number of adverse Events (including injection site reactions)
Pharmacokinetics: terminal half-life, trough values, serum concentrations
Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
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)

Full Information

First Posted
November 16, 2009
Last Updated
August 14, 2014
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01018238
Brief Title
An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Why Stopped
See detailed description
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
Cohort 2
Arm Type
Experimental
Arm Title
Cohort 3
Arm Type
Experimental
Arm Title
Cohort 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC 0151-0000-0000
Intervention Description
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)
Primary Outcome Measure Information:
Title
Observed adverse events
Time Frame
From day -28 to day 113
Secondary Outcome Measure Information:
Title
Number of adverse Events (including injection site reactions)
Time Frame
Every visit through study completion (Day 113)
Title
Pharmacokinetics: terminal half-life, trough values, serum concentrations
Time Frame
Day 1 through Day 113
Title
Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
Time Frame
Day 1 through Day 113
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042-1008
Country
United States

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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