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CompletedNCT01203631Updated Aug 1, 2016

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

A Phase 2 interventional study of NNC 0142-0000-0002 and Placebo in Inflammation and Crohn's Disease, sponsored by Janssen Research & Development, LLC. Completed at 23 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-01.

Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Inflammation
  • Crohn's Disease
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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 78 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    NNC 0142-0000-0002

    Drug: NNC 0142-0000-0002

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugNNC 0142-0000-0002

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

  • DrugPlacebo

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

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What researchers measure

Primary outcomes

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

    Time frame: From baseline to week 4

Secondary outcomes

  1. Number of adverse events (AEs)

    Time frame: From baseline to weeks 12 and 24

  2. Immunogenicity of NNC 142-0002

    Time frame: At week 24

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Study locations

23 sites
  • Novo Nordisk Clinical Trial Call Center
    Anaheim, California 92801, United States
  • Novo Nordisk Clinical Trial Call Center
    Lakewood, Colorado 80215, United States
  • Novo Nordisk Clinical Trial Call Center
    Chicago, Illinois 60637, United States
  • Novo Nordisk Clinical Trial Call Center
    Louisville, Kentucky 40202, United States
  • Novo Nordisk Clinical Trial Call Center
    Annapolis, Maryland 21401, United States
  • Novo Nordisk Clinical Trial Call Center
    Chevy Chase, Maryland 20815, United States
  • Novo Nordisk Clinical Trial Call Center
    Towson, Maryland 21204, United States
  • Novo Nordisk Clinical Trial Call Center
    Chesterfield, Michigan 48047, United States
  • Novo Nordisk Clinical Trial Call Center
    Troy, Michigan 48098, United States
  • Novo Nordisk Clinical Trial Call Center
    New York, New York 10029, United States
  • Novo Nordisk Clinical Trial Call Center
    Asheville, North Carolina 28801-4109, United States
  • Novo Nordisk Clinical Trial Call Center
    Fayetteville, North Carolina 28304, United States
  • Novo Nordisk Clinical Trial Call Center
    Raleigh, North Carolina 27612, United States
  • Novo Nordisk Clinical Trial Call Center
    Germantown, Tennessee 38138-1741, United States
  • Novo Nordisk Clinical Trial Call Center
    Charlottesville, Virginia 22911, United States
  • Novo Nordisk Clinical Trial Call Center
    Milwaukee, Wisconsin 53215-5217, United States
  • Leuven, 3000, Belgium
  • Edmonton, Alberta T6G 2X8, Canada
  • Paris, 75010, France
  • Gyor, 9024, Hungary
  • Kfar Saba, 44281, Israel
  • Warszawa, 02-507, Poland
  • Saint-Petersburg, 195067, Russian Federation
08

References and documents

Publications

  • 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. PubMed 27489241 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01203631
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Sep 16, 2010
Start date
Feb 2011
Primary completion
May 2013
Completion
May 2013
Last update
Aug 1, 2016

Study contacts

Najat EL Bariaki
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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