Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

July 29, 2016 updated by: Janssen Research & Development, LLC

A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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

  • Belgium
      • Leuven, Belgium, 3000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
  • France
      • Paris, France, 75010
  • Hungary
      • Gyor, Hungary, 9024
  • Israel
      • Kfar Saba, Israel, 44281
  • Poland
      • Warszawa, Poland, 02-507
  • Russian Federation
      • Saint-Petersburg, Russian Federation, 195067
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Clinical Trial Call Center
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Novo Nordisk Clinical Trial Call Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Novo Nordisk Clinical Trial Call Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Novo Nordisk Clinical Trial Call Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Novo Nordisk Clinical Trial Call Center
      • Chevy Chase, Maryland, United States, 20815
        • Novo Nordisk Clinical Trial Call Center
      • Towson, Maryland, United States, 21204
        • Novo Nordisk Clinical Trial Call Center
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Novo Nordisk Clinical Trial Call Center
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Clinical Trial Call Center
    • New York
      • New York, New York, United States, 10029
        • Novo Nordisk Clinical Trial Call Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801-4109
        • Novo Nordisk Clinical Trial Call Center
      • Fayetteville, North Carolina, United States, 28304
        • Novo Nordisk Clinical Trial Call Center
      • Raleigh, North Carolina, United States, 27612
        • Novo Nordisk Clinical Trial Call Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138-1741
        • Novo Nordisk Clinical Trial Call Center
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Novo Nordisk Clinical Trial Call Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215-5217
        • Novo Nordisk Clinical Trial Call Center

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:

  • Subjects with CD for at least 3 months
  • Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound

Exclusion Criteria:

  • Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess
  • History of dysplasia or malignancy in the colon
  • Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
  • Body mass index (BMI) higher or equal to 38.0 kg/m^2

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 dose administered subcutaneously (s.c., under the skin)
Experimental: NNC 0142-0000-0002
Drug: NNC 0142-0000-0002
A single dose administered subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in disease activity assessed by CDAI (Crohn's disease activity index)
Time Frame: From baseline to week 4
From baseline to week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events (AEs)
Time Frame: From baseline to weeks 12 and 24
From baseline to weeks 12 and 24
Immunogenicity of NNC 142-0002
Time Frame: At week 24
At week 24

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Najat EL Bariaki, 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.

General Publications

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, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8555-3797
  • 2010-020836-21 (EudraCT Number)
  • U1111-1116-2695 (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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