This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
Change in Crohn's disease activity index (CDAI)
Time frame: Week 0, week 4
Change in CDAI
Time frame: Week 0, week 12
Clinical remission, defined as CDAI of less than 150
Time frame: At week 8
Change in the inflammatory bowel disease questionnaire (IBDQ) score
Time frame: Week 0, week 4
Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores
Time frame: Week 0, week 4
Incidence of adverse events (AEs)
Time frame: Up to weeks 24 or 36
Incidence of anti-NNC0114-0006 antibodies
Time frame: Up to weeks 24 or 36
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Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Laguna Hills, California, United States
Novo Nordisk Investigational Site
Clearwater, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States
Novo Nordisk Investigational Site
Jackson, Tennessee, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Sofia, Bulgaria
...and 18 more locations