An Investigation of Safety and Tolerability of NNC0114-00... | NCT01689025

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

NCT01689025

Sponsor

Novo Nordisk A/S

Status

Terminated

Last Update Posted

Apr 8, 2014Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Inflammation
Systemic Lupus Erythematosus

Interventions

NNC0114-0006
placebo

Countries

United States
Hungary
Poland
Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-005699-41	EudraCT Number
U1111-1125-9646	Other Identifier	WHO

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Sep 14, 2012

First Submission Date that Met QC Criteria

Sep 14, 2012

First Posted Date

Sep 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2014

Last Update Posted Date

Apr 8, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NNC0114-0006	Experimental		Drug: NNC0114-0006
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NNC0114-0006	Drug	Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.	NNC0114-0006

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs)		From first administration of the trial product and up to week 26

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Clinical Trial Call Center		La Jolla	California	92093	United States
Novo Nordisk Clinical Trial Call Center

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided