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

Primary Purpose

Inflammation, Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NNC 0142-0000-0002
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC 0142-0000-0002

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in disease activity assessed by CDAI (Crohn's disease activity index)

Secondary Outcome Measures

Number of adverse events (AEs)
Immunogenicity of NNC 142-0002

Full Information

First Posted
September 15, 2010
Last Updated
July 29, 2016
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01203631
Brief Title
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NNC 0142-0000-0002
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NNC 0142-0000-0002
Intervention Description
A single dose administered subcutaneously (s.c., under the skin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single dose administered subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
Change in disease activity assessed by CDAI (Crohn's disease activity index)
Time Frame
From baseline to week 4
Secondary Outcome Measure Information:
Title
Number of adverse events (AEs)
Time Frame
From baseline to weeks 12 and 24
Title
Immunogenicity of NNC 142-0002
Time Frame
At week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najat EL Bariaki
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801-4109
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138-1741
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215-5217
Country
United States
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
City
Paris
ZIP/Postal Code
75010
Country
France
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
27489241
Citation
Allez M, Skolnick BE, Wisniewska-Jarosinska M, Petryka R, Overgaard RV. Anti-NKG2D monoclonal antibody (NNC0142-0002) in active Crohn's disease: a randomised controlled trial. Gut. 2017 Nov;66(11):1918-1925. doi: 10.1136/gutjnl-2016-311824. Epub 2016 Aug 3.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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