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
Status and phase
Completed
Phase 2
Conditions
Inflammation
Crohn's Disease
Treatments
Drug: NNC0114-0006
Drug: placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
53 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
53 participants in 2 patient groups, including a placebo group
NNC0114-0006
Experimental group
Treatment:
Drug: NNC0114-0006
Placebo
Placebo Comparator group
Treatment:
Drug: placebo
Trial contacts and locations
28
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Data sourced from clinicaltrials.gov
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