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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT01689025
Collaborator
(none)
10
Enrollment
5
Locations
2
Arms
17
Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: NNC0114-0006

Drug: NNC0114-0006
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events (AEs) [From first administration of the trial product and up to week 26]

Secondary Outcome Measures

  1. PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½) [After the last dosing (Week 6)]

  2. PK endpoint from serum NNC0114-0006: Accumulation based on the concentration [2 weeks after the first (week 2) and the last dose (week 8)]

  3. Change in serum levels of total IL-21 (Interleukin-21) [Week 0, week 26]

  4. Change in disease activity (SELENA-SLEDAI) [Week 0, week 12]

  5. Change in corticosteroid usage [Week 0, week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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/m2 or above 38 kg/m2

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Clinical Trial Call Center La Jolla California United States 92093
2 Novo Nordisk Clinical Trial Call Center Houston Texas United States 77034
3 Szeged Hungary 6720
4 Poznan Poland 60-218
5 Belgrade Serbia 11000

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01689025
Other Study ID Numbers:
  • NN8828-4002
  • 2011-005699-41
  • U1111-1125-9646
First Posted:
Sep 20, 2012
Last Update Posted:
Apr 8, 2014
Last Verified:
Apr 1, 2014
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Inflammation

Study Results

No Results Posted as of Apr 8, 2014