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

G

Generium

Status and phase

Enrolling
Phase 3

Conditions

Still's Disease Adult Onset

Treatments

Biological: Ilaris®
Biological: GNR-086

Study type

Interventional

Funder types

Industry

Identifiers

NCT06497491
CAN-AOSD-III

Details and patient eligibility

About

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, Switzerland) in the treatment of patients with adult-onset Still's disease. Participants will receive a subcutaneous canakinumab 4 mg/kg every 4 weeks. The treatment duration is 24 weeks following with the study extension.

Full 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 the immuniglobulin G1 (IgG1(kappa)) isotype that binds specifically and with high affinity to interleukin-1β (IL-1β). Canakinumab, by binding to human IL-1β, blocks the interaction of this cytokine with its receptors, thereby functionally neutralizing the biological activity of this cytokine, without preventing either the binding of the natural inhibitor IL-1Ra, or the binding of IL-1α to IL-1 receptors. IL-1β is recognized as one of the main pro-inflammatory cytokines in various inflammatory conditions.

This III phase study is aimed to compare the efficacy, safety and immunogenicity of GNR-086 and Ilaris®. The study will enroll patients with the confirmed diagnosis of adult-onset Still's disease in accordance with the classification criteria of Yamaguchi M. et al. (J. Rheumatology, 1992), and the duration of the disease at least 2 months before inclusion into the study. 148 paitnts will be randomised 2:1 to receive either GNR-098 or Ilaris®. Participants will receive canakinumab 4 mg/kg suncutaneously every 4 weeks for 24 weeks following the study extension.

Enrollment

148 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

148 participants in 2 patient groups

GNR-086
Experimental group
Description:
canakinumab biosimilar
Treatment:
Biological: GNR-086
Ilaris®
Active Comparator group
Description:
canakinumab
Treatment:
Biological: Ilaris®

Trial contacts and locations

17

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Central trial contact

Oksana A. Markova, MD; Evgeny V. Zuev, MD

Data sourced from clinicaltrials.gov

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