Systemic Lupus Erythematosus Clinical Trial
Official title:
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus
The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I
clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary
results showed acceptable safety profile and patients developped antibodies response.
The principal aim of the present study is to confirm the neutralization of the interferon
gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the
immune responses and the safety elicited by IFN-K will also be evaluated.
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