NCT01689025

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
4 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

September 14, 2012

Last Update Submit

April 7, 2014

Conditions

InflammationSystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events (AEs)

    From first administration of the trial product and up to week 26

Secondary Outcomes (5)

  • PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)

    After the last dosing (Week 6)

  • PK endpoint from serum NNC0114-0006: Accumulation based on the concentration

    2 weeks after the first (week 2) and the last dose (week 8)

  • Change in serum levels of total IL-21 (Interleukin-21)

    Week 0, week 26

  • Change in disease activity (SELENA-SLEDAI)

    Week 0, week 12

  • Change in corticosteroid usage

    Week 0, week 12

Study Arms (2)

NNC0114-0006

EXPERIMENTAL
Drug: NNC0114-0006

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

NNC0114-0006DRUG

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

NNC0114-0006
placeboDRUG

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novo Nordisk Clinical Trial Call Center

La Jolla, California, 92093, United States

Location

Novo Nordisk Clinical Trial Call Center

Houston, Texas, 77034, United States

Location

Unknown Facility

Szeged, 6720, Hungary

Location

Unknown Facility

Poznan, 60-218, Poland

Location

Unknown Facility

Belgrade, 11000, Serbia

Location

Related Links

MeSH Terms

Conditions

InflammationLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 20, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

HU(1)PL(1)SE(1)US(2)