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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01689025
• Other study ID #: NN8828-4002
• Secondary ID: 2011-005699-41U1
• Status: Terminated
• Phase: Phase 1
• First received: September 14, 2012
• Last updated: April 7, 2014
• Start date: September 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Ministry of Health, Social and Family AffairsPoland: Ministry of Health and Social SecuritySerbia: Medicines and Medical Devices Agency of SerbiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		From first administration of the trial product and up to week 26	No
Secondary	PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)		After the last dosing (Week 6)	No
Secondary	PK endpoint from serum NNC0114-0006: Accumulation based on the concentration		2 weeks after the first (week 2) and the last dose (week 8)	No
Secondary	Change in serum levels of total IL-21 (Interleukin-21)		Week 0, week 26	No
Secondary	Change in disease activity (SELENA-SLEDAI)		Week 0, week 12	No
Secondary	Change in corticosteroid usage		Week 0, week 12	No

External Links

•   Clinical Trials at Novo Nordisk