InflammationPhase 2NCT01203631
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2 study testing NNC 0142-0000-0002 in people with Inflammation and Crohn's Disease, run by Janssen Research & Development, LLC at 23 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation, Crohn's Disease
- What is being tested?
- NNC 0142-0000-0002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Feb 2011to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States16 sites
Novo Nordisk Clinical Trial Call Center
Anaheim, California, 92801
Novo Nordisk Clinical Trial Call Center
Annapolis, Maryland, 21401
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, 28801-4109
Novo Nordisk Clinical Trial Call Center
Charlottesville, Virginia, 22911
Novo Nordisk Clinical Trial Call Center
Chesterfield, Michigan, 48047
Novo Nordisk Clinical Trial Call Center
Chevy Chase, Maryland, 20815
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, 60637
Novo Nordisk Clinical Trial Call Center
Fayetteville, North Carolina, 28304
Novo Nordisk Clinical Trial Call Center
Germantown, Tennessee, 38138-1741
Novo Nordisk Clinical Trial Call Center
Lakewood, Colorado, 80215
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, 40202
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, 53215-5217
Novo Nordisk Clinical Trial Call Center
New York, New York, 10029
Novo Nordisk Clinical Trial Call Center
Raleigh, North Carolina, 27612
Novo Nordisk Clinical Trial Call Center
Towson, Maryland, 21204
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, 48098
About this study
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
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.
- Conditions
- Inflammation, Crohn's Disease
- Being tested
- NNC 0142-0000-0002, Placebo
- Medical subject headings
- Inflammation, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC 0142-0000-0002Drug
A single dose administered subcutaneously (s.c., under the skin)
PlaceboDrug
A single dose administered subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NNC 0142-0000-0002 | Experimental | Not described Receives: Drug: NNC 0142-0000-0002 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity assessed by CDAI (Crohn's disease activity index)
Measured: From baseline to week 4
Secondary outcomes (2)
Number of adverse events (AEs)
Measured: From baseline to weeks 12 and 24
Immunogenicity of NNC 142-0002
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Najat EL Bariaki, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203631
- Sponsor's protocol ID
- NN8555-3797
- Other IDs
- 2010-020836-21, U1111-1116-2695
- Status last verified
- Jul 2016
- First submitted
- 15 Sep 2010
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01203631
- Acronym / sponsor ID
- NN8555-3797
- Conditions
- Inflammation, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC 0142-0000-0002 | Experimental | Drug: NNC 0142-0000-0002 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC 0142-0000-0002A single dose administered subcutaneously (s.c., under the skin) | Drug | NNC 0142-0000-0002 |
| PlaceboA single dose administered subcutaneously (s.c., under the skin) | Drug | Placebo |
Primary outcome
Change in disease activity assessed by CDAI (Crohn's disease activity index)
Time frame: From baseline to week 4
2 secondary outcomes
Number of adverse events (AEs)
Time frame: From baseline to weeks 12 and 24
Immunogenicity of NNC 142-0002
Time frame: At week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Derived from this study: PubMed 27489241Allez 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najat EL Bariaki study director
Novo Nordisk A/S
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC 0142-0000-0002 in people with Inflammation and Crohn's Disease, run by Janssen Research & Development, LLC at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Belgium, Canada, France, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity assessed by CDAI (Crohn's disease activity index) (time frame: From baseline to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.