NCT06497491

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

A Single-blind Randomized Study of the Efficacy and Safety of the GNR-086 (Canakinumab Proposed Biosimilar) in Comparison With the Ilaris®, Conducted in Parallel Groups of Patients With Adult-onset Still's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, 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.

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 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.

Conditions

• Still's Disease Adult Onset

Interventions

Type	Name	Description
BIOLOGICAL	GNR-086	GNR-086 is administered as a subcutaneous injection at a dose of 4 mg/kg once every 4 weeks for 24 weeks.
BIOLOGICAL	Ilaris®	Ilaris® is administered as a subcutaneous injection at a dose of 4 mg/kg once every 4 weeks for 24 weeks.

Timeline

• Start date: 2023-12-12
• Primary completion: 2025-05-29
• Completion: 2025-07-10
• First posted: 2024-07-11
• Last updated: 2025-08-17

Locations

17 sites across 1 country: Russia