Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497491
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-05
Brief Title:
An Efficacy and Safety Study of GNR-086 canakinumab Biosimilar and Ilaris in Patients with Adult-onset Still39s Disease
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
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 Still39s Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized single-blind comparative parallel group study of the efficacy and safety of canakinumab biosimilar GNR-086 JSC 34GENERIUM34 Russia and Ilaris Novartis Pharma Stein AG Switzerland in the treatment of patients with adult-onset Still39s disease Participants will receive a subcutaneous canakinumab 4 mgkg 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 IgG1kappa 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 Still39s 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 21 to receive either GNR-098 or Ilaris Participants will receive canakinumab 4 mgkg suncutaneously every 4 weeks for 24 weeks following the study extension
Canakinumab is a fully human monoclonal antibody of the immuniglobulin G1 IgG1kappa 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 Still39s 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 21 to receive either GNR-098 or Ilaris Participants will receive canakinumab 4 mgkg suncutaneously every 4 weeks for 24 weeks following the study extension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None