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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01689025 |
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Date of registration:
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14/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
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Scientific title:
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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 |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01689025 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Hungary
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Poland
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Serbia
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inflammation
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: NNC0114-0006
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Drug: placebo
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Primary Outcome(s)
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Incidence of Adverse Events (AEs)
[Time Frame: From first administration of the trial product and up to week 26]
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Secondary Outcome(s)
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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)]
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Change in corticosteroid usage
[Time Frame: Week 0, week 12]
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PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)
[Time Frame: After the last dosing (Week 6)]
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Change in serum levels of total IL-21 (Interleukin-21)
[Time Frame: Week 0, week 26]
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Change in disease activity (SELENA-SLEDAI)
[Time Frame: Week 0, week 12]
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Secondary ID(s)
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2011-005699-41
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U1111-1125-9646
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NN8828-4002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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