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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01203631
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : August 1, 2016
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammation Crohn's Disease Drug: NNC 0142-0000-0002 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NNC 0142-0000-0002 Drug: NNC 0142-0000-0002
A single dose administered subcutaneously (s.c., under the skin)
Placebo Comparator: Placebo Drug: Placebo
A single dose administered subcutaneously (s.c., under the skin)

Primary Outcome Measures :
  1. Change in disease activity assessed by CDAI (Crohn's disease activity index) [ Time Frame: From baseline to week 4 ]

Secondary Outcome Measures :
  1. Number of adverse events (AEs) [ Time Frame: From baseline to weeks 12 and 24 ]
  2. Immunogenicity of NNC 142-0002 [ Time Frame: At week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203631

  Show 23 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Najat EL Bariaki Novo Nordisk A/S

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01203631     History of Changes
Other Study ID Numbers: NN8555-3797
2010-020836-21 ( EudraCT Number )
U1111-1116-2695 ( Other Identifier: WHO )
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Crohn Disease
Pathologic Processes
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases