Clinical trial NCT01203631: Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
Official title: A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Crohn's Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 NNC 0142-0000-0002.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in disease activity assessed by CDAI (Crohn's disease activity index)
timeFrame: From baseline to week 4
Secondary outcomes:
measure: Number of adverse events (AEs)
timeFrame: From baseline to weeks 12 and 24
measure: Immunogenicity of NNC 142-0002
timeFrame: At week 24
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Lakewood
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Colorado
city: Chicago
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Illinois
city: Louisville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Kentucky
city: Annapolis
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Maryland
city: Chevy Chase
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Maryland
city: Towson
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Maryland
city: Chesterfield
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Michigan
city: Troy
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Michigan
city: New York
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New York
city: Asheville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: North Carolina
city: Fayetteville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: North Carolina
city: Raleigh
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: North Carolina
city: Germantown
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Tennessee
city: Charlottesville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Virginia
city: Milwaukee
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Wisconsin
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Paris
country: France
city: Gyor
country: Hungary
city: Kfar Saba
country: Israel
city: Warszawa
country: Poland
city: Saint-Petersburg
country: Russian Federation
Study officials:
affiliation: Novo Nordisk A/S
name: Najat EL Bariaki
role: STUDY_DIRECTOR
References:
citation: 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.