Status:
COMPLETED
An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease
Lead Sponsor:
AO GENERIUM
Conditions:
Still's Disease Adult Onset
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized single-blind comparative parallel group study of the efficacy and safety of canakinumab biosimilar GNR-086 (JSC \"GENERIUM\", Russia) and Ilaris® (Novartis Pharma Stein AG...
Detailed Description
GNR-086 is being developed as a proposed biosimilar to Ilaris®, a lyophilisate for the preparation of a solution for subcutaneous administration. Canakinumab is a fully human monoclonal antibody of t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06497491
Start Date
December 12 2023
End Date
July 10 2025
Last Update
August 17 2025
Active Locations (17)
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1
State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Chelyabinsk Oblast, Russia, 454076
2
Limited Liability Company "Medical Center "Revma-Med"
Kemerovo, Kemerovo Oblast, Russia, 650070
3
Limited Liability Company "OLLA-MED"
Moscow, Moscow, Russia, 105554
4
Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova"
Moscow, Moscow, Russia, 115522