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

Completed · Phase 2 · Has a placebo group

Conditions studied: Inflammation, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01751152

Run by

Novo Nordisk A/S

People needed

53

Starts

2013-02-01

Expected to finish

2014-12-01

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Tucson, Arizona, United States
• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States
• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States
• Novo Nordisk Investigational Site — Laguna Hills, California, United States
• Novo Nordisk Investigational Site — Clearwater, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Jefferson City, Missouri, United States
• Novo Nordisk Investigational Site — Jackson, Tennessee, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Sofia, Bulgaria
• Novo Nordisk Investigational Site — Sofia, Bulgaria
• Novo Nordisk Investigational Site — Varna, Bulgaria
• Novo Nordisk Investigational Site — Hradec Králové, Czechia
• Novo Nordisk Investigational Site — Olomouc, Czechia
• Novo Nordisk Investigational Site — Olomouc, Czechia
• Novo Nordisk Investigational Site — Prague, Czechia
• Novo Nordisk Investigational Site — Częstochowa, Poland
• Novo Nordisk Investigational Site — Szczecin, Poland
• Novo Nordisk Investigational Site — Banská Bystrica, Slovakia
• Novo Nordisk Investigational Site — Bratislava, Slovakia
• Novo Nordisk Investigational Site — Ružomberok, Slovakia
• Novo Nordisk Investigational Site — Barcelona, Spain
• Novo Nordisk Investigational Site — Barcelona, Spain
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Santander, Spain

Full record on ClinicalTrials.gov

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