Crohns disease MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Code: 0114-0006B
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: N/A
Current Sponsor code: NNC0114-0006
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Moderately to severely active Crohn’s disease, defined as a CDAI of 220-450 (both inclusive) at Visit 2 (Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) =10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Screening). - Men and women between =18 and =75 years of age (for Czech Republic only: Men and women between =18 and =65 years of age) - 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 two marketed biologic therapy for the treatment of Crohn’s disease due to lack of efficacy (primary or secondary efficacy failures). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: - Body mass index (BMI) =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect on disease activity of a single i.v. dose of NNC0114-0006 with placebo in subjects with moderately to severely active Crohn’s disease;Secondary Objective: - To describe the pharmacokinetics (PK) of NNC0114-0006 - To compare pharmacodynamic (PD) effects of NNC0114-0006 and placebo - To compare the effects of NNC0114-0006 and placebo on mucosal healing in a subgroup of subjects - To compare the effects of NNC0114-0006 and placebo on the use of concomitant medication for Crohn’s disease - To compare the effects of NNC0114-0006 and placebo on patient reported outcomes (PROs) - To describe the safety and tolerability of NNC0114-0006 - To describe the immunogenicity of NNC0114-0006;Primary end point(s): Change in Crohn’s disease activity index (CDAI) ;Timepoint(s) of evaluation of this end point: From baseline to Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in CDAI 2. Clinical remission, defined as CDAI of less than 150 3. Change in the inflammatory bowel disease questionnaire (IBDQ) score 4. Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores 5. Incidence of adverse events (AEs) 6. Incidence of anti-NNC0114-0006 antibodies ;Timepoint(s) of evaluation of this end point: 1. From baseline to Week 12 2. At Week 8 3. From baseline to Week 4 4. From baseline to Week 4 5. Up to Weeks 24 or 36 6. Up to Weeks 24 or 36 | — |
Countries
Bulgaria, Czech Republic, Hungary, Poland, Russian Federation, Serbia, Slovakia, Spain, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed