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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01751152

Collaborator

(none)

Enrollment

Locations

Arms

21.9

Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Crohn's Disease	Drug: NNC0114-0006 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0114-0006	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.
Placebo Comparator: Placebo	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.

Arm

Intervention/Treatment

Experimental: NNC0114-0006

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.

Placebo Comparator: Placebo

Drug: placebo

Outcome Measures

Primary Outcome Measures

Change in Crohn's disease activity index (CDAI) [Week 0, week 4]

Secondary Outcome Measures

Change in CDAI [Week 0, week 12]
Clinical remission, defined as CDAI of less than 150 [At week 8]
Change in the inflammatory bowel disease questionnaire (IBDQ) score [Week 0, week 4]
Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores [Week 0, week 4]
Incidence of adverse events (AEs) [Up to weeks 24 or 36]
Incidence of anti-NNC0114-0006 antibodies [Up to weeks 24 or 36]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Tucson	Arizona	United States	85710
2	Novo Nordisk Investigational Site	Little Rock	Arkansas	United States	72205
3	Novo Nordisk Investigational Site	Little Rock	Arkansas	United States	72212
4	Novo Nordisk Investigational Site	Laguna Hills	California	United States	92653
5	Novo Nordisk Investigational Site	Clearwater	Florida	United States	33759
6	Novo Nordisk Investigational Site	Miami	Florida	United States	33136
7	Novo Nordisk Investigational Site	Jefferson City	Missouri	United States	65109
8	Novo Nordisk Investigational Site	Jackson	Tennessee	United States	38305
9	Novo Nordisk Investigational Site	Houston	Texas	United States	77062
10	Novo Nordisk Investigational Site	Sofia		Bulgaria	1431
11	Novo Nordisk Investigational Site	Sofia		Bulgaria	1527
12	Novo Nordisk Investigational Site	Varna		Bulgaria	9010
13	Novo Nordisk Investigational Site	Hradec Kralove		Czech Republic	500 12
14	Novo Nordisk Investigational Site	Olomouc		Czech Republic	775 00
15	Novo Nordisk Investigational Site	Olomouc		Czech Republic	77520
16	Novo Nordisk Investigational Site	Praha 5		Czech Republic	15006
17	Novo Nordisk Investigational Site	Czestochowa		Poland	42-202
18	Novo Nordisk Investigational Site	Szczecin		Poland	71-252
19	Novo Nordisk Investigational Site	Banská Bystrica		Slovakia	974 05
20	Novo Nordisk Investigational Site	Bratislava		Slovakia	831 04
21	Novo Nordisk Investigational Site	Ruzomberok		Slovakia	034 26
22	Novo Nordisk Investigational Site	Barcelona		Spain	08022
23	Novo Nordisk Investigational Site	Barcelona		Spain	08028
24	Novo Nordisk Investigational Site	Madrid		Spain	28942
25	Novo Nordisk Investigational Site	Santander		Spain	39008
26	Novo Nordisk Investigational Site	Sevilla		Spain	41013
27	Novo Nordisk Investigational Site	Sevilla		Spain	41014
28	Novo Nordisk Investigational Site	Valencia		Spain	46026

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01751152

Other Study ID Numbers:

NN8828-4004
2012-002432-93
U1111-1130-8441

First Posted:

Dec 17, 2012

Last Update Posted:

Mar 31, 2017

Last Verified:

Mar 1, 2017

Additional relevant MeSH terms:

Crohn Disease

Inflammation

Study Results

No Results Posted as of Mar 31, 2017