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

Completed · Phase 2 · Has a placebo group

Conditions studied: Inflammation, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01203631

Run by

Janssen Research & Development, LLC

People needed

78

Starts

2011-02-01

Expected to finish

2013-05-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Clinical Trial Call Center — Anaheim, California, United States
• Novo Nordisk Clinical Trial Call Center — Lakewood, Colorado, United States
• Novo Nordisk Clinical Trial Call Center — Chicago, Illinois, United States
• Novo Nordisk Clinical Trial Call Center — Louisville, Kentucky, United States
• Novo Nordisk Clinical Trial Call Center — Annapolis, Maryland, United States
• Novo Nordisk Clinical Trial Call Center — Chevy Chase, Maryland, United States
• Novo Nordisk Clinical Trial Call Center — Towson, Maryland, United States
• Novo Nordisk Clinical Trial Call Center — Chesterfield, Michigan, United States
• Novo Nordisk Clinical Trial Call Center — Troy, Michigan, United States
• Novo Nordisk Clinical Trial Call Center — New York, New York, United States
• Novo Nordisk Clinical Trial Call Center — Asheville, North Carolina, United States
• Novo Nordisk Clinical Trial Call Center — Fayetteville, North Carolina, United States
• Novo Nordisk Clinical Trial Call Center — Raleigh, North Carolina, United States
• Novo Nordisk Clinical Trial Call Center — Germantown, Tennessee, United States
• Novo Nordisk Clinical Trial Call Center — Charlottesville, Virginia, United States
• Novo Nordisk Clinical Trial Call Center — Milwaukee, Wisconsin, United States
• Study site — Leuven, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — Paris, France
• Study site — Győr, Hungary
• Study site — Kfar Saba, Israel
• Study site — Warsaw, Poland
• Study site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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