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A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease

NCT ID: NCT01751152

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.

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Detailed Description

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Conditions

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Inflammation Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC0114-0006

Group Type EXPERIMENTAL

NNC0114-0006

Intervention Type DRUG

A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.

Interventions

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NNC0114-0006

A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.

Intervention Type DRUG

placebo

A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderately to severely active Crohn's disease, defined as a Crohn's disease activity index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Day -28 to -7, Screening)
* Biologic-naïve subjects or biologic-experienced for the treatment of Crohn's disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn's disease due to lack of efficacy (primary or secondary efficacy failures)

Exclusion Criteria

* Body mass index (BMI) equal to or above 38.0 kg/m\^2
* Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated
* History of dysplasia in the colon
* Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy
* Any history of serious recurrent infections requiring hospitalisation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Tucson, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Site Status

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Site Status

Novo Nordisk Investigational Site

Laguna Hills, California, United States

Site Status

Novo Nordisk Investigational Site

Clearwater, Florida, United States

Site Status

Novo Nordisk Investigational Site

Miami, Florida, United States

Site Status

Novo Nordisk Investigational Site

Jefferson City, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Jackson, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Varna, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Hradec Králové, , Czechia

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Częstochowa, , Poland

Site Status

Novo Nordisk Investigational Site

Szczecin, , Poland

Site Status

Novo Nordisk Investigational Site

Banská Bystrica, , Slovakia

Site Status

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Ružomberok, , Slovakia

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Santander, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Countries

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United States Bulgaria Czechia Poland Slovakia Spain

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-002432-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1130-8441

Identifier Type: OTHER

Identifier Source: secondary_id

NN8828-4004

Identifier Type: -

Identifier Source: org_study_id

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