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

Phase 1

Terminated

• Conditions: Inflammation; Systemic Lupus Erythematosus
• Interventions: Drug: placebo; Drug: NNC0114-0006

• Registration Number: NCT01689025
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-20
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC0114-0006	NNC0114-0006	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	From first administration of the trial product and up to week 26

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Houston, Texas, United States