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

• Register: EUCTR
• Last refreshed on: 24 August 2015
• Main ID: EUCTR2012-002432-93-CZ
• Date of registration: 05/09/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public 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
• Scientific 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
• Date of first enrolment: 18/01/2013
• Target sample size: 114
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002432-93
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Bulgaria, Czech Republic, Hungary, Poland, Russian Federation, Serbia, Slovakia, Spain, United States

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohns disease
MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

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
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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

Primary end point(s): Change in Crohn’s disease activity index (CDAI)

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

Timepoint(s) of evaluation of this end point: From baseline to Week 4

Secondary Outcome(s)

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

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

Secondary ID(s)

NN8828-4004

Source(s) of Monetary Support

Novo Nordisk A/S