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

NCT06497491 | Completed Phase 3

• 1 other identifier: CAN-AOSD-III
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 17

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, 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.

Conditions

Still's Disease Adult Onset

Keywords

canakinumab; humanized monoclonal antibodies; safety; Still's disease adult onset; equivalence; biosimilar; American College of Rheumatology (ACR); DAS28; disease-modifying anti-rheumatic drugs (DMARDs); European League Against Rheumatism (EULAR); immunogenicity

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a clinically significant (>1.2 points) decrease in the Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR)

  A composite index and takes into account the following items: Tender joint count (number of tender joints; 0-28); swollen joint count (number of swollen joints; 0-28); ESR (mm/h) and Global Health (Patient's Global Assessment of Disease Activity; from 0=best to 100=worst). Thus, given the reliability, validity, and ability of DAS28 to discriminate the severity of joint involvement, this index has been used in other rheumatic diseases characterized by rheumatoid artritis (RA)-like poly-articular involvement. Of note, a DAS28 score \> 5.1 implies active disease, ≤3.2 low disease activity, and \<2.6 remission. Moderate/high disease activity is defined as a DAS28 higher than 3.2.

  Week 12

Secondary Outcomes (10)

• Change in DAS28-ESR/C-reactive protein (CRP) score

  Week 24

• Proportion of patients with an American College of Rheumatology score (ACR) 30/50/70/90/100 response without fever associated with the underlying disease during the 7 days preceding the day of assessment

  Week 24

• Area under the curve (AUC) of the disease activity rate (ACR)

  Week 24

• Proportion of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

  Week 24

• Area under the curve (AUC) of CRP concentration

  Week 24

Study Arms (2)

GNR-086

EXPERIMENTAL

canakinumab biosimilar

Biological: GNR-086

Ilaris®

ACTIVE COMPARATOR

canakinumab

Biological: Ilaris®

Interventions

GNR-086 BIOLOGICAL

GNR-086 is administered as a subcutaneous injection at a dose of 4 mg/kg once every 4 weeks for 24 weeks.

Also known as: canakinumab biosimilar

GNR-086

Ilaris® BIOLOGICAL

Ilaris® is administered as a subcutaneous injection at a dose of 4 mg/kg once every 4 weeks for 24 weeks.

Also known as: canakinumab

Ilaris®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (17)

State budgetary healthcare institution &#34;Chelyabinsk Regional Clinical Hospital&#34;

Chelyabinsk, Chelyabinsk Oblast, 454076, Russia

Location

Limited Liability Company &#34;Medical Center &#34;Revma-Med&#34;

Kemerovo, Kemerovo Oblast, 650070, Russia

Location

Limited Liability Company &#34;OLLA-MED&#34;

Moscow, Moscow, 105554, Russia

Location

Federal State Budgetary Institution &#34;Research Institute of Rheumatology named after V.A. Nasonova&#34;

Moscow, Moscow, 115522, Russia

Location

State budgetary healthcare institution of the city of Moscow &#34;City Clinical Hospital No. 52 of the Moscow Health Department&#34; (GBUZ &#34;City Clinical Hospital No. 52 DZM&#34;)

Moscow, Moscow, 123182, Russia

Location

Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N. I. Pirogova

Moscow, Moscow, 129226, Russia

Location

Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N.I. Pirogov Ministry of Health of Russia Separate structural unit "Russian Gerontological Scientific and Clinical Center"

Moscow, Moscow, 129226, Russia

Location

Limited Liability Company &#34;Medical Center &#34;Healthy Family&#34;

Novosibirsk, Novosibirsk Oblast, 630099, Russia

Location

Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia

Orenburg, Orenburg Oblast, 460018, Russia

Location

Limited Liability Company &#34;Medical Technologies&#34; LLC &#34;Medical Technologies&#34;

Saint Petersburg, Sankt-Peterburg, 192148, Russia

Location

Limited Liability Company &#34;Ex Seven Clinical Research&#34;

Saint Petersburg, Sankt-Peterburg, 194156, Russia

Location

Limited Liability Company &#34;Interleukin&#34;

Saint Petersburg, Sankt-Peterburg, 194214, Russia

Location

State Budgetary Healthcare Institution Leningrad area Clinical Hospital

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

Private foundation &#34;RZD-Medicine&#34; Smolensk&#34;

Smolensk, Smolensk Oblast, 214025, Russia

Location

Limited Liability Company &#34;BioMed&#34;

Vladimir, Vladimirskaya Oblast’, 600005, Russia

Location

State health care institution city clinical hospital №25

Volgograd, Volgograd Oblast, 400138, Russia

Location

State Budgetary Healthcare Institution "Clinical Hospital No. 2"

Yaroslavl, Yaroslavl Oblast, 150030, Russia

Location

MeSH Terms

Conditions

Wissler's Syndrome

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Rheumatic Fever; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hypersensitivity; Immune System Diseases

Study Officials

• Oksana A. Markova, MD

  JSC GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Analitial laboratory to assess imunogenicity
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: December 12, 2023
• Primary Completion: May 29, 2025
• Study Completion: July 10, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (17)