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):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01203631
First received: September 15, 2010
Last updated: November 19, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in disease activity assessed by CDAI (Crohn's disease activity index) [ Time Frame: From baseline to week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events (AEs) [ Time Frame: From baseline to weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Immunogenicity of NNC 142-0002 [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Locations
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Lakewood, Colorado, United States, 80215
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Annapolis, Maryland, United States, 21401
Novo Nordisk Clinical Trial Call Center
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, United States, 48098
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Fayetteville, North Carolina, United States, 28304
Novo Nordisk Clinical Trial Call Center
Raleigh, North Carolina, United States, 27612
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Germantown, Tennessee, United States, 38138-1741
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Charlottesville, Virginia, United States, 22911
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53215-5217
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Najat EL Bariaki Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01203631     History of Changes
Other Study ID Numbers: NN8555-3797, 2010-020836-21, U1111-1116-2695
Study First Received: September 15, 2010
Last Updated: November 19, 2013
Health Authority: Belgium: Federal Agency for Medicines and Healthcare Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014