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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751152
• Other study ID #: NN8828-4004
• Secondary ID: 2012-002432-93U1
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2012
• Last updated: March 30, 2017
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammation

Intervention

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
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.

Locations

Country	Name	City	State
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Varna
Czech Republic	Novo Nordisk Investigational Site	Hradec Kralove
Czech Republic	Novo Nordisk Investigational Site	Olomouc
Czech Republic	Novo Nordisk Investigational Site	Olomouc
Czech Republic	Novo Nordisk Investigational Site	Praha 5
Poland	Novo Nordisk Investigational Site	Czestochowa
Poland	Novo Nordisk Investigational Site	Szczecin
Slovakia	Novo Nordisk Investigational Site	Banská Bystrica
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Ruzomberok
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Santander
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Valencia
United States	Novo Nordisk Investigational Site	Clearwater	Florida
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Jackson	Tennessee
United States	Novo Nordisk Investigational Site	Jefferson City	Missouri
United States	Novo Nordisk Investigational Site	Laguna Hills	California
United States	Novo Nordisk Investigational Site	Little Rock	Arkansas
United States	Novo Nordisk Investigational Site	Little Rock	Arkansas
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Crohn's disease activity index (CDAI)		Week 0, week 4
Secondary	Change in CDAI		Week 0, week 12
Secondary	Clinical remission, defined as CDAI of less than 150		At week 8
Secondary	Change in the inflammatory bowel disease questionnaire (IBDQ) score		Week 0, week 4
Secondary	Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores		Week 0, week 4
Secondary	Incidence of adverse events (AEs)		Up to weeks 24 or 36
Secondary	Incidence of anti-NNC0114-0006 antibodies		Up to weeks 24 or 36

External Links

•   Clinical Trials at Novo Nordisk