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

March 30, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1527
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
      • Varna, Bulgaria, 9010
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 12
        • Novo Nordisk Investigational Site
      • Olomouc, Czech Republic, 775 00
        • Novo Nordisk Investigational Site
      • Olomouc, Czech Republic, 77520
        • Novo Nordisk Investigational Site
      • Praha 5, Czech Republic, 15006
        • Novo Nordisk Investigational Site
  • Poland
      • Czestochowa, Poland, 42-202
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 71-252
        • Novo Nordisk Investigational Site
  • Slovakia
      • Banská Bystrica, Slovakia, 974 05
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 831 04
        • Novo Nordisk Investigational Site
      • Ruzomberok, Slovakia, 034 26
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08022
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08028
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28942
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39008
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41014
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novo Nordisk Investigational Site
      • Little Rock, Arkansas, United States, 72212
        • Novo Nordisk Investigational Site
    • California
      • Laguna Hills, California, United States, 92653
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77062
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Experimental: NNC0114-0006
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Crohn's disease activity index (CDAI)
Time Frame: Week 0, week 4
Week 0, week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in CDAI
Time Frame: Week 0, week 12
Week 0, week 12
Clinical remission, defined as CDAI of less than 150
Time Frame: At week 8
At week 8
Change in the inflammatory bowel disease questionnaire (IBDQ) score
Time Frame: Week 0, week 4
Week 0, week 4
Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores
Time Frame: Week 0, week 4
Week 0, week 4
Incidence of adverse events (AEs)
Time Frame: Up to weeks 24 or 36
Up to weeks 24 or 36
Incidence of anti-NNC0114-0006 antibodies
Time Frame: Up to weeks 24 or 36
Up to weeks 24 or 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8828-4004
  • 2012-002432-93 (EudraCT Number)
  • U1111-1130-8441 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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