Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Feb 2013

Geographic Reach

6 countries

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

December 13, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed

2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed

Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

December 13, 2012

Last Update Submit

March 30, 2017

Conditions

Inflammation Crohn's Disease

Outcome Measures

Primary Outcomes (1)

Change in Crohn's disease activity index (CDAI)
Week 0, week 4

Secondary Outcomes (6)

Change in CDAI
Week 0, week 12
Clinical remission, defined as CDAI of less than 150
At week 8
Change in the inflammatory bowel disease questionnaire (IBDQ) score
Week 0, week 4
Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores
Week 0, week 4
Incidence of adverse events (AEs)
Up to weeks 24 or 36
+1 more secondary outcomes

Study Arms (2)

NNC0114-0006

EXPERIMENTAL

Drug: NNC0114-0006

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

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.

NNC0114-0006

placeboDRUG

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.