Generium obtaines permission to conduct clinical trial on Ilaris

Generium obtaines permission to conduct clinical trial on Ilaris
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The Ministry of Health has granted approval to the Russian company Generium to conduct a clinical study on GNR-086 (canakinumab), which is a counterpart of Ilaris, an original drug developed by Novartis. According to the State Register of Medicinal Remedies, the study aims to compare the clinical effectiveness of GNR-086 and Ilaris in patients with adult Still's disease who require repeated treatment. It is anticipated that the trials will be completed by 2026.

The drug will be administered to patients through subcutaneous injections in parallel groups. The study will be conducted across 13 medical centers located in Moscow, St. Petersburg, Yaroslavl, Novosibirsk, Smolensk, Orenburg, Kemerovo, Volgograd, Vladimir, and Chelyabinsk.

Canakinumab, the medication being tested, has demonstrated high efficacy in treating systemic juvenile idiopathic arthritis and active Still's disease, including in adults. This monoclonal antibody specifically targets interleukin-1 beta in humans and does not interact with other members of the interleukin-1 family, such as interleukin-1 alpha.