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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751152
First Posted: December 17, 2012
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

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 ]

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

Enrollment: 53
Study Start Date: February 2013
Study Completion Date: December 2014
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: 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.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751152


  Show 28 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01751152     History of Changes
Other Study ID Numbers: NN8828-4004
2012-002432-93 ( EudraCT Number )
U1111-1130-8441 ( Other Identifier: WHO )
First Submitted: December 13, 2012
First Posted: December 17, 2012
Last Update Posted: March 31, 2017
Last Verified: March 2017

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