Crohn's Disease Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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