InflammationPhase 2NCT01751152
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
A Phase 2 study testing NNC0114-0006 in people with Inflammation and Crohn's Disease, run by Novo Nordisk A/S at 28 sites in 6 countries.
Trial summary
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. 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?
- NNC0114-0006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 28 sitesin 6 countries
- Study dates
- Feb 2013to Dec 2014
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States9 sites
Novo Nordisk Investigational Site
Clearwater, Florida, 33759
Novo Nordisk Investigational Site
Houston, Texas, 77062
Novo Nordisk Investigational Site
Jackson, Tennessee, 38305
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Laguna Hills, California, 92653
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72205
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72212
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Tucson, Arizona, 85710
Spain7 sites
Novo Nordisk Investigational Site
Barcelona, 08022
Novo Nordisk Investigational Site
Barcelona, 08028
Novo Nordisk Investigational Site
Madrid, 28942
Novo Nordisk Investigational Site
Santander, 39008
Novo Nordisk Investigational Site
Seville, 41013
Novo Nordisk Investigational Site
Seville, 41014
Novo Nordisk Investigational Site
Valencia, 46026
Czechia4 sites
Novo Nordisk Investigational Site
Hradec Králové, 500 12
Novo Nordisk Investigational Site
Olomouc, 775 00
Novo Nordisk Investigational Site
Olomouc, 77520
Novo Nordisk Investigational Site
Prague, 15006
Bulgaria3 sites
Novo Nordisk Investigational Site
Sofia, 1431
Novo Nordisk Investigational Site
Sofia, 1527
Novo Nordisk Investigational Site
Varna, 9010
Slovakia3 sites
Novo Nordisk Investigational Site
Banská Bystrica, 974 05
Novo Nordisk Investigational Site
Bratislava, 831 04
Novo Nordisk Investigational Site
Ružomberok, 034 26
Poland2 sites
Novo Nordisk Investigational Site
Częstochowa, 42-202
Novo Nordisk Investigational Site
Szczecin, 71-252
About this study
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.
- Conditions
- Inflammation, Crohn's Disease
- Being tested
- NNC0114-0006, 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.
NNC0114-0006Drug
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.
placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NNC0114-0006 | Experimental | Not described Receives: Drug: NNC0114-0006 |
| 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 Crohn's disease activity index (CDAI)
Measured: Week 0, week 4
Secondary outcomes (6)
Change in CDAI
Measured: Week 0, week 12
Clinical remission, defined as CDAI of less than 150
Measured: At week 8
Change in the inflammatory bowel disease questionnaire (IBDQ) score
Measured: Week 0, week 4
Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores
Measured: Week 0, week 4
Incidence of adverse events (AEs)
Measured: Up to weeks 24 or 36
Incidence of anti-NNC0114-0006 antibodies
Measured: Up to weeks 24 or 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751152
- Sponsor's protocol ID
- NN8828-4004
- Other IDs
- 2012-002432-93, U1111-1130-8441
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2012
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01751152
- Acronym / sponsor ID
- NN8828-4004
- Conditions
- Inflammation, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Dec 2012 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0114-0006 | Experimental | Drug: NNC0114-0006 |
| 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)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| NNC0114-0006A 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. | Drug | NNC0114-0006 |
| placeboA 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. | Drug | Placebo |
Primary outcome
Change in Crohn's disease activity index (CDAI)
Time frame: Week 0, week 4
6 secondary outcomes
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
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 31 Mar 2017.
- 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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0114-0006 in people with Inflammation and Crohn's Disease, run by Novo Nordisk A/S at 28 sites in 6 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 5 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Spain, Czechia, Bulgaria, Slovakia and 1 more country. 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 Crohn's disease activity index (CDAI) (time frame: Week 0, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2017; AzTrials last refreshed its copy on 29 Oct 2026.