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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01203631
First received: September 15, 2010
Last updated: July 29, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Inflammation
Crohn's Disease
Drug: NNC 0142-0000-0002
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

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

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

Enrollment: 78
Study Start Date: February 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203631

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

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 )
Study First Received: September 15, 2010
Last Updated: July 29, 2016

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

ClinicalTrials.gov processed this record on April 25, 2017