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

• Conditions: Crohns disease; MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-002432-93-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-25
• Last Update Posted: 9 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 114

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
- 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).
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- To compare pharmacodynamic (PD) effects of NNC0114-0006 and placebo<br>- To compare the effects of NNC0114-0006 and placebo on mucosal healing in a subgroup of subjects <br>- To compare the effects of NNC0114-0006 and placebo on the use of concomitant medication for Crohn’s disease<br>- To compare the effects of NNC0114-0006 and placebo on patient reported outcomes (PROs)<br>- To describe the safety and tolerability of NNC0114-0006<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in CDAI <br>2. Clinical remission, defined as CDAI of less than 150 <br>3. Change in the inflammatory bowel disease questionnaire (IBDQ) score <br>4. Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores<br>5. Incidence of adverse events (AEs) <br>6. Incidence of anti-NNC0114-0006 antibodies ;Timepoint(s) of evaluation of this end point: 1. From baseline to Week 12<br>2. At Week 8<br>3. From baseline to Week 4<br>4. From baseline to Week 4<br>5. Up to Weeks 24 or 36<br>6. Up to Weeks 24 or 36