Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
NCT ID: NCT01203631
Last Updated: 2016-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2011-02-28
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NNC 0142-0000-0002
NNC 0142-0000-0002
A single dose administered subcutaneously (s.c., under the skin)
Placebo
Placebo
A single dose administered subcutaneously (s.c., under the skin)
Interventions
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NNC 0142-0000-0002
A single dose administered subcutaneously (s.c., under the skin)
Placebo
A single dose administered subcutaneously (s.c., under the skin)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Najat EL Bariaki
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Leuven, , Belgium
Edmonton, Alberta, Canada
Paris, , France
Győr, , Hungary
Kfar Saba, , Israel
Warsaw, , Poland
Saint Petersburg, , Russia
Countries
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References
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Allez M, Skolnick BE, Wisniewska-Jarosinska M, Petryka R, Overgaard RV. Anti-NKG2D monoclonal antibody (NNC0142-0002) in active Crohn's disease: a randomised controlled trial. Gut. 2017 Nov;66(11):1918-1925. doi: 10.1136/gutjnl-2016-311824. Epub 2016 Aug 3.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2010-020836-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1116-2695
Identifier Type: OTHER
Identifier Source: secondary_id
NN8555-3797
Identifier Type: -
Identifier Source: org_study_id
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