Status:
COMPLETED
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Inflammation
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01203631
Start Date
February 1 2011
End Date
May 1 2013
Last Update
August 1 2016
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
2
Novo Nordisk Clinical Trial Call Center
Lakewood, Colorado, United States, 80215
3
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60637
4
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40202