Neovacs has initiated a treatment in a Phase II clinical trial to evaluate TNFa-Kinoid (TNF-K) in rheumatoid arthritis patients who have failed treatment with an anti-TNFa monoclonal antibody.
This randomised, double-blind, placebo-controlled Phase II study is being conducted in France, Belgium and Switzerland.
All the necessary regulatory authorisations have been received, and the trial will enroll up to 48 patients.
The primary objective is to select the dose levels and dosing schedule to be tested in a subsequent Phase IIb/III study.
The treatment's safety and clinical efficacy are secondary endpoints.
The trial results are expected in mid-2011 and will be followed by a Phase IIb/III trial.
