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Trial record 2 of 5 for:    NNC0114­-0006

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

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ClinicalTrials.gov Identifier: NCT01689025
Recruitment Status : Terminated
First Posted : September 20, 2012
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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
Inflammation Systemic Lupus Erythematosus Drug: NNC0114-0006 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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.




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: After the last dosing (Week 6) ]
  2. 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) ]
  3. Change in serum levels of total IL-21 (Interleukin-21) [ Time Frame: Week 0, week 26 ]
  4. Change in disease activity (SELENA-SLEDAI) [ Time Frame: Week 0, week 12 ]
  5. Change in corticosteroid usage [ Time Frame: Week 0, week 12 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689025


Locations
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United States, California
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92093
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77034
Hungary
Szeged, Hungary, 6720
Poland
Poznan, Poland, 60-218
Serbia
Belgrade, Serbia, 11000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01689025     History of Changes
Other Study ID Numbers: NN8828-4002
2011-005699-41 ( EudraCT Number )
U1111-1125-9646 ( Other Identifier: WHO )
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Inflammation
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases