Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01203631
First received: September 15, 2010
Last updated: May 21, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
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 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203631
Locations
| United States, Illinois | |
| Novo Nordisk Clinical Trial Call Center | |
| Chicago, Illinois, United States, 60637 | |
| 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 | |
| London, Canada, N6A 5A5 | |
| France | |
| Paris, France, 75010 | |
| Hungary | |
| Gyor, Hungary, 9024 | |
| Israel | |
| Kfar Saba, Israel, 44281 | |
| Poland | |
| Warszawa, Poland, 03-580 | |
| Russian Federation | |
| Saint-Petersburg, Russian Federation, 195067 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Najat EL Bariaki | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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: | May 21, 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 May 21, 2013