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

Primary Purpose

Inflammation, Systemic Lupus Erythematosus

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

NNC0114-0006

placebo

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Clinical Trial Call Center
Novo Nordisk Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0114-0006

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs)

Secondary Outcome Measures

PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)

PK endpoint from serum NNC0114-0006: Accumulation based on the concentration

Change in serum levels of total IL-21 (Interleukin-21)

Change in disease activity (SELENA-SLEDAI)

Change in corticosteroid usage

Full Information

NCT ID

NCT01689025

First Posted

September 14, 2012

Last Updated

April 7, 2014

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01689025

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0114-0006

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC0114-0006

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs)

Time Frame

From first administration of the trial product and up to week 26

Secondary Outcome Measure Information:

Title

PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)

Time Frame

After the last dosing (Week 6)

Title

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)

Title

Change in serum levels of total IL-21 (Interleukin-21)

Time Frame

Week 0, week 26

Title

Change in disease activity (SELENA-SLEDAI)

Time Frame

Week 0, week 12

Title

Change in corticosteroid usage

Time Frame

Week 0, week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Clinical Trial Call Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Novo Nordisk Clinical Trial Call Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

City

Poznan

ZIP/Postal Code

60-218

Country

Poland

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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