An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

April 7, 2014 updated by: Novo Nordisk A/S

A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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

  • Hungary
      • Szeged, Hungary, 6720
  • Poland
      • Poznan, Poland, 60-218
  • Serbia
      • Belgrade, Serbia, 11000
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Novo Nordisk Clinical Trial Call Center
    • Texas
      • Houston, Texas, United States, 77034
        • 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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women (not pregnant and not nursing)
  • Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
  • Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
  • If taken, background medication must be stable

Exclusion Criteria:

  • Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
  • Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
Experimental: NNC0114-0006
Drug: NNC0114-0006
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: From first administration of the trial product and up to week 26
From first administration of the trial product and up to week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)
Time Frame: After the last dosing (Week 6)
After the last dosing (Week 6)
PK endpoint from serum NNC0114-0006: Accumulation based on the concentration
Time Frame: 2 weeks after the first (week 2) and the last dose (week 8)
2 weeks after the first (week 2) and the last dose (week 8)
Change in serum levels of total IL-21 (Interleukin-21)
Time Frame: Week 0, week 26
Week 0, week 26
Change in disease activity (SELENA-SLEDAI)
Time Frame: Week 0, week 12
Week 0, week 12
Change in corticosteroid usage
Time Frame: Week 0, week 12
Week 0, week 12

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

September 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8828-4002
  • 2011-005699-41 (EudraCT Number)
  • U1111-1125-9646 (Other Identifier: 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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