Crohn's Disease, Inflammation
Conditions
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.
Interventions
DRUGNNC0114-0006
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.
DRUGplacebo
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Crohn's disease activity index (CDAI) | Week 0, week 4 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in CDAI | Week 0, week 12 |
| Incidence of adverse events (AEs) | Up to weeks 24 or 36 |
| Incidence of anti-NNC0114-0006 antibodies | Up to weeks 24 or 36 |
| Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores | Week 0, week 4 |
Countries
Bulgaria, Czechia, Poland, Slovakia, Spain, United States
Outcome results
None listed