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Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01203631
Collaborator
(none)
78
Enrollment
23
Locations
2
Arms
26.9
Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.

Condition or Disease Intervention/Treatment Phase
  • Drug: NNC 0142-0000-0002
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: NNC 0142-0000-0002

Drug: NNC 0142-0000-0002
A single dose administered subcutaneously (s.c., under the skin)
Placebo Comparator: Placebo

Drug: Placebo
A single dose administered subcutaneously (s.c., under the skin)

Outcome Measures

Primary Outcome Measures

  1. Change in disease activity assessed by CDAI (Crohn's disease activity index) [From baseline to week 4]

Secondary Outcome Measures

  1. Number of adverse events (AEs) [From baseline to weeks 12 and 24]

  2. Immunogenicity of NNC 142-0002 [At week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subjects with CD for at least 3 months

  • Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound

Exclusion Criteria:

  • Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess

  • History of dysplasia or malignancy in the colon

  • Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation

  • Body mass index (BMI) higher or equal to 38.0 kg/m^2

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Clinical Trial Call Center Anaheim California United States 92801
2 Novo Nordisk Clinical Trial Call Center Lakewood Colorado United States 80215
3 Novo Nordisk Clinical Trial Call Center Chicago Illinois United States 60637
4 Novo Nordisk Clinical Trial Call Center Louisville Kentucky United States 40202
5 Novo Nordisk Clinical Trial Call Center Annapolis Maryland United States 21401
6 Novo Nordisk Clinical Trial Call Center Chevy Chase Maryland United States 20815
7 Novo Nordisk Clinical Trial Call Center Towson Maryland United States 21204
8 Novo Nordisk Clinical Trial Call Center Chesterfield Michigan United States 48047
9 Novo Nordisk Clinical Trial Call Center Troy Michigan United States 48098
10 Novo Nordisk Clinical Trial Call Center New York New York United States 10029
11 Novo Nordisk Clinical Trial Call Center Asheville North Carolina United States 28801-4109
12 Novo Nordisk Clinical Trial Call Center Fayetteville North Carolina United States 28304
13 Novo Nordisk Clinical Trial Call Center Raleigh North Carolina United States 27612
14 Novo Nordisk Clinical Trial Call Center Germantown Tennessee United States 38138-1741
15 Novo Nordisk Clinical Trial Call Center Charlottesville Virginia United States 22911
16 Novo Nordisk Clinical Trial Call Center Milwaukee Wisconsin United States 53215-5217
17 Leuven Belgium 3000
18 Edmonton Alberta Canada T6G 2X8
19 Paris France 75010
20 Gyor Hungary 9024
21 Kfar Saba Israel 44281
22 Warszawa Poland 02-507
23 Saint-Petersburg Russian Federation 195067

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

  • Study Director: Najat EL Bariaki, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01203631
Other Study ID Numbers:
  • NN8555-3797
  • 2010-020836-21
  • U1111-1116-2695
First Posted:
Sep 16, 2010
Last Update Posted:
Aug 1, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Crohn Disease
Inflammation

Study Results

No Results Posted as of Aug 1, 2016