Home › Trials › NCT06497491

Comparing GNR-086 and Ilaris® for treating 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

Phase 3 Interventional Ao Generium · NCT06497491

This study is testing if a new treatment called GNR-086 works as well and is as safe as Ilaris® for adults with adult-onset Still's disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment148 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAo Generium Industry-sponsored
Drugs / interventionscanakinumab, tocilizumab, sarilumab, olokizumab, adalimumab, golimumab, rituximab, methotrexate
Locations17 sites (Chelyabinsk, Chelyabinsk region and 16 other locations)
Trial IDNCT06497491 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of GNR-086, a biosimilar to Ilaris®, in patients diagnosed with adult-onset Still's disease. It is a randomized, single-blind, comparative study where participants will receive subcutaneous injections of either GNR-086 or Ilaris® at a dosage of 4 mg/kg every four weeks for a total duration of 24 weeks. The study aims to assess not only the effectiveness of the treatments but also their safety and immunogenicity. A total of 148 patients will be enrolled, with a 2:1 randomization ratio between the two treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with a confirmed diagnosis of adult-onset Still's disease and active disease symptoms.

Not a fit: Patients with a duration of adult-onset Still's disease of less than two months or those not meeting the disease activity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective and potentially more accessible treatment option for patients with adult-onset Still's disease.

How similar studies have performed: Other studies have shown success with similar monoclonal antibody treatments for inflammatory conditions, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chelyabinsk, Chelyabinsk region and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Still's Disease Adult Onsetcanakinumabhumanized monoclonal antibodiessafetyStill's disease adult onsetequivalencebiosimilarAmerican College of Rheumatology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.