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

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
InflammationCrohn's Disease
Interventions
DRUG

NNC0114-0006

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.

DRUG

placebo

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.

Trial Locations (28)

1431

Novo Nordisk Investigational Site, Sofia

1527

Novo Nordisk Investigational Site, Sofia

9010

Novo Nordisk Investigational Site, Varna

15006

Novo Nordisk Investigational Site, Prague

28942

Novo Nordisk Investigational Site, Madrid

33136

Novo Nordisk Investigational Site, Miami

33759

Novo Nordisk Investigational Site, Clearwater

38305

Novo Nordisk Investigational Site, Jackson

39008

Novo Nordisk Investigational Site, Santander

41013

Novo Nordisk Investigational Site, Seville

41014

Novo Nordisk Investigational Site, Seville

46026

Novo Nordisk Investigational Site, Valencia

65109

Novo Nordisk Investigational Site, Jefferson City

72205

Novo Nordisk Investigational Site, Little Rock

72212

Novo Nordisk Investigational Site, Little Rock

77062

Novo Nordisk Investigational Site, Houston

77520

Novo Nordisk Investigational Site, Olomouc

85710

Novo Nordisk Investigational Site, Tucson

92653

Novo Nordisk Investigational Site, Laguna Hills

500 12

Novo Nordisk Investigational Site, Hradec Králové

775 00

Novo Nordisk Investigational Site, Olomouc

42-202

Novo Nordisk Investigational Site, Częstochowa

71-252

Novo Nordisk Investigational Site, Szczecin

974 05

Novo Nordisk Investigational Site, Banská Bystrica

831 04

Novo Nordisk Investigational Site, Bratislava

034 26

Novo Nordisk Investigational Site, Ružomberok

08022

Novo Nordisk Investigational Site, Barcelona

08028

Novo Nordisk Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY