The primary objective of the study is to evaluate the efficacy and safety of goflikicept (GFC) and olokizumab (OKZ) in patients with Still's disease
Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
Confirmed diagnosis of Adult-Onset Still's Disease (AOSD) based on the Yamaguchi M. diagnostic criteria
Patient with active disease or low disease activity per DAVID criteria
In case of current corticosteroid (CS) use, doses must be stable for at least 2 weeks prior to Day 0. The maximum allowed dose of CS is 1 mg/kg/day, up to 60 mg/day (prednisolone equivalent)
Hypersensitivity to the active and/or inactive ingredients of the investigational product
Rilonacept - less than 6 weeks prior to Day 0
Canakinumab - less than 20 weeks prior to Day 0
Anakinra - less than 1 week prior to Day 0
Parallel
Placebo
Drug0.9% Sodium Chloride solution for Injection
Goflikicept
Biological/Vaccinesolution for subcutaneous injection and intravenous infusion, 40 mg/mL
Olokizumab
Biological/Vaccinesolution for subcutaneous injection and intravenous infusion, 160 mg/mL
Proportion of patients who achieved and maintained low disease activity or remission according to DAVID criteria at Day 7 (excluding the arthritis criterion) and achieved DAVID remission criteria at Day 28
Low disease activity according to DAVID criteria is defined as the absence of fever and the presence of only one of the following criteria: * typical skin rash * arthritis * C-reactive protein (CRP) level \> 10 mg/L * Patient's global assessment of arthritis (PtGA) ≥ 5 cm Remission according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA \< 5 cm
Proportion of patients who developed a flare of Still's disease within 24 weeks after randomization
Flare is defined as the occurrence of criteria consistent with low disease activity starting from Day 28 Low disease activity according to DAVID criteria is defined as the absence of fever and the presence of only one of the following criteria: * typical skin rash * arthritis * C-reactive protein (CRP) level \> 10 mg/L * Patient's global assessment of arthritis (PtGA) ≥ 5 cm
Proportion of patients with resolution of fever on Day 3 and Day 7
Proportion of patients with resolution of fever on Day 3 and Day 7
Proportion of patients who achieved inactive disease while on low-dose glucocorticosteroids (0.1 mg/kg/day) during the study
Inactive disease according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA \< 5 cm
Proportion of patients who achieved inactive disease without glucocorticosteroids during the study
Inactive disease according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA \< 5 cm
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Number of patients with clinically significant laboratory abnormalities
Laboratory assessments include complete blood count, blood biochemistry, lipid profile, fibrinogen, ferritin, and urinalysis
Number of patients with clinically significant vital sign abnormalities
Vital signs include blood pressure (mmHg), heart rate (beats per minute), and respiratory rate (breaths per minute)
Change from baseline in heart rate assessed by electrocardiography (ECG)
Electrocardiography (ECG) is performed in 12 leads (I, II, III, aVR, aVL, aVF, V1-V6) to assess heart rate
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