A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease

• Conditions: Crohn’s 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: EUCTR2010-020836-21-PL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-28
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Men and women (not pregnant and not nursing) of =18 and =75 years of age
- Subjects with CD for at least 3 months having active disease with a CDAI score of =220 and =450 and evidence of inflammation confirmed by a C-reactive protein (CRP) level =10 mg/L (or =1.0 mg/dL) or endoscopic verification
- Biologic-naïve subjects or biologic-experienced for the treatment of CD having discontinued due to lack of efficacy to only one biologic therapy (primary or secondary failure), intolerance to therapy, or other reasons (e.g. drug holiday).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess
• History of dysplasia or malignancy in the colon
• Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
• Body mass index (BMI) =38.0 kg/m^2

Study & Design

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