An Efficacy and Safety Study of GNR-086 (canakinumab Biosimilar) and Ilaris® in Patients with Adult-onset Still's Disease

- Availability of written informed consent obtained from the patient before the start of any procedures related to the study.

- Male and female patients aged 18-75 years, inclusive, at the time of signing the informed consent form.

- Patients with a documented diagnosis of adult Still's disease in accordance with the classification criteria of Yamaguchi M. et al. (J. Rheumatology, 1992) and the duration of the disease is at least 2 months before signing the Informed Consent Form.

- Disease activity ≥2.6 according to DAS28-ESR.

- No change in the dosing regimen of methotrexate (maximum 20 mg/m2/week) or other immunosuppressive agent for at least 6 weeks before randomization and/or no change in the dosing regimen of one nonsteroidal anti-inflammatory drug (NSAID) as treatment for adult Still's disease for at least 14 days before randomization and/or no change in the dosage regimen of the glucocorticosteroid drug for at least 7 days before randomization.

- Negative result of intradermal test with tuberculosis allergen / IGRA test at screening or within 6 months before screening. Patients with missing screening data can only be included in the study if they undergo immunodiagnosis of tuberculosis infection and the result is negative.

- Agreement to adhere to adequate methods of contraception throughout the study and for 3 months after the end of canakinumab therapy.

- Diagnosis of macrophage activation syndrome (MAS) within the last 3 months.

- History of hypersensitivity to the active substance or other components of the study or reference drug.

- Acute infectious diseases within 14 days before randomization.

- Immunization with any live vaccine within 3 months before randomization.

- Concomitant diseases and conditions that, in the opinion of the Investigator and/or Sponsor, jeopardize the safety of the patient during participation in the study, or which will influence the analysis of safety data.

- Blood donation or blood loss (450 ml of blood or more) less than 2 months before the start of the study.

- Pregnancy or breastfeeding.

- History of tuberculosis (except for successfully treated primary tuberculosis complex no later than 6 months before randomization).

- Use of the following treatments before randomization: anakinra within 1 week before randomization; etanercept within 6 weeks before randomization; tocilizumab within 8 weeks before randomization; sarilumab within 6 weeks before randomization; olokizumab for 8 weeks before randomization; adalimumab within 10 weeks before randomization; golimumab within 16 weeks before randomization; rituximab within 26 weeks before randomization; leflunomide within 6 weeks before randomization; cyclosporine within 4 weeks before randomization; intravenous immunoglobulin within 8 weeks before randomization; growth hormone within 4 weeks before randomization; intra-articular, periarticular, intravenous, intramuscular administration of glucocorticosteroids within 4 weeks before randomization; any other unapproved drugs within 5 half-lives before randomization.

- Drug dependence on drugs and potent drugs and/or alcohol dependence.

- Positive test results for hepatitis B or C, HIV or syphilis.

- Unwillingness or inability to comply with the recommendations prescribed by this protocol.

- Identification during screening of other diseases/conditions not listed above that, in the opinion of the physician-researcher, prevent the inclusion of the patient in the study.