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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01751152
First received: December 13, 2012
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Inflammation
Crohn's Disease
Drug: NNC0114-0006
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Crohn's disease activity index (CDAI) [ Time Frame: Week 0, week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in CDAI [ Time Frame: Week 0, week 12 ] [ Designated as safety issue: No ]
  • Clinical remission, defined as CDAI of less than 150 [ Time Frame: At week 8 ] [ Designated as safety issue: No ]
  • Change in the inflammatory bowel disease questionnaire (IBDQ) score [ Time Frame: Week 0, week 4 ] [ Designated as safety issue: No ]
  • Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores [ Time Frame: Week 0, week 4 ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to weeks 24 or 36 ] [ Designated as safety issue: No ]
  • Incidence of anti-NNC0114-0006 antibodies [ Time Frame: Up to weeks 24 or 36 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751152

Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Tucson, Arizona, United States, 85710
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72212
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72205
United States, Florida
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33759
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Jackson, Tennessee, United States, 38305
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77062
Bulgaria
Sofia, Bulgaria, 1527
Czech Republic
Olomouc, Czech Republic, 775 00
Poland
Czestochowa, Poland, 42-202
Russian Federation
Nizhniy Novgorod, Russian Federation, 603126
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Slovakia
Ruzomberok, Slovakia, 034 26
Spain
Barcelona, Spain, 08022
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01751152     History of Changes
Other Study ID Numbers: NN8828-4004, 2012-002432-93, U1111-1130-8441
Study First Received: December 13, 2012
Last Updated: September 4, 2014
Health Authority: Bulgaria: Ministry of Health
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Medicines and Medical Devices Agency of Serbia
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines and Health Care Products
United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Crohn Disease
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014