NCT01291810

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Neovacs · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	TNF Kinoid	TNF Kinoid
BIOLOGICAL	WFI	WFI

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-10-01
• Completion: 2014-05-01
• First posted: 2011-02-08
• Last updated: 2014-09-18

Locations

58 sites across 9 countries: Belgium, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Netherlands, Romania