A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/1/2017
Start Date:February 2013
End Date:December 2014

Use our guide to learn which trials are right for you!

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.


Inclusion Criteria:

- Moderately to severely active Crohn's disease, defined as a Crohn's disease activity
index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of
inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or
endoscopic verification (according to endoscopy imaging manual) performed at Visit 1
(Day -28 to -7, Screening)

- Biologic-naïve subjects or biologic-experienced for the treatment of Crohn's disease.
Biologic-experienced subjects are eligible if they have not failed more than one
marketed biologic therapy for the treatment of Crohn's disease due to lack of
efficacy (primary or secondary efficacy failures)

Exclusion Criteria:

- Body mass index (BMI) equal to or above 38.0 kg/m^2

- Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy
or colostomy, surgical bowel resection within 6 months prior to randomisation, total
colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses
not adequately treated

- History of dysplasia in the colon

- Any active or ongoing bacterial infections within 4 weeks prior to randomisation,
unless treated and resolved with appropriate therapy

- Any history of serious recurrent infections requiring hospitalisation
We found this trial at
9
sites
?
mi
from
Sofia,
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jefferson City, Missouri 65109
?
mi
from
Jefferson City, MO
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72202
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Tucson, Arizona 85704
?
mi
from
Tucson, AZ
Click here to add this to my saved trials