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Still's Disease Adult OnsetPhase 3NCT06497491

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

A Phase 3 study testing GNR-086 and Ilaris® in people with Still's Disease Adult Onset, run by AO GENERIUM at 17 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Still's Disease Adult Onset
What is being tested?
GNR-086 and Ilaris®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
17 sitesRussia
Study dates
12 Dec 2023to 10 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

17 sites in 1 country.

17 sites in 1 country

Russia17 sites

  • State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital"

    Chelyabinsk, Chelyabinsk Oblast, 454076

  • Limited Liability Company "Medical Center "Revma-Med"

    Kemerovo, Kemerovo Oblast, 650070

  • Limited Liability Company "OLLA-MED"

    Moscow, Moscow, 105554

  • Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova"

    Moscow, Moscow, 115522

  • State budgetary healthcare institution of the city of Moscow "City Clinical Hospital No. 52 of the Moscow Health Department" (GBUZ "City Clinical Hospital No. 52 DZM")

    Moscow, Moscow, 123182

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

    Moscow, Moscow, 129226

  • 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

  • Limited Liability Company "Medical Center "Healthy Family"

    Novosibirsk, Novosibirsk Oblast, 630099

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

    Orenburg, Orenburg Oblast, 460018

  • Limited Liability Company "Medical Technologies" LLC "Medical Technologies"

    Saint Petersburg, Sankt-Peterburg, 192148

  • Limited Liability Company "Ex Seven Clinical Research"

    Saint Petersburg, Sankt-Peterburg, 194156

  • Limited Liability Company "Interleukin"

    Saint Petersburg, Sankt-Peterburg, 194214

  • State Budgetary Healthcare Institution Leningrad area Clinical Hospital

    Saint Petersburg, Sankt-Peterburg, 194291

  • Private foundation "RZD-Medicine" Smolensk"

    Smolensk, Smolensk Oblast, 214025

  • Limited Liability Company "BioMed"

    Vladimir, Vladimirskaya Oblast’, 600005

  • State health care institution city clinical hospital №25

    Volgograd, Volgograd Oblast, 400138

  • State Budgetary Healthcare Institution "Clinical Hospital No. 2"

    Yaroslavl, Yaroslavl Oblast, 150030

Other trials in Russia

About this study

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 Still's Disease

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.

Read the 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.

Being tested
GNR-086, Ilaris®
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
Medical subject headings
Wissler's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNR-086Biological

    Also called canakinumab biosimilar

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

  • Ilaris®Biological

    Also called canakinumab

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

Study groups in NCT06497491
Study groupRoleWhat they receive
GNR-086Experimentalcanakinumab biosimilar
Receives: Biological: GNR-086
Ilaris®Active comparatorcanakinumab
Receives: Biological: Ilaris®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (10)

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

    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) / CRP (mg/l) 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 RA-like poly-articular involvement.

    Measured: Week 24

  2. 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

    The ACR30/50/70/90/100 response: greater than or equal to (>/=) 30/50/70/90/100 percent (%) improvement in TJC and SJC (28 assessed joints), and 30/50/70/90/100 % improvement in 3 of the following 5 criteria, respectively: 1) physician's assessment Global Disease Activity (PhGDA), 2) Patients assessment Global Disease Activity (PtGDA), 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR

    Measured: Week 24

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

    ACR response criteria measure percentage reduction in 68 painful joints, percentage reduction in 66 swollen joints, and percentage improvement in at least three of the following: Patients assessment Global Disease Activity (PtGDA), physician's assessment Global Disease Activity (PhGDA), Patient Pain Assessment , assessment according to the health assessment questionnaire disability index (HAQ-DI), CRP concentration value.

    Measured: Week 24

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

    The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 </=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1; non-responders: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1

    Measured: Week 24

  5. Area under the curve (AUC) of CRP concentration

    CRP values standardized to a normal range

    Measured: Week 24

  6. Area under the curve (AUC) of ESR

    ESR values standardized to a normal range

    Measured: Week 24

  7. Area under the curve (AUC) of ferritin levels

    Ferritin values standardized to a normal range

    Measured: Week 24

  8. Proportion of patients with no rash within 24 hours before the end of the 1st week of treatment; and within 7 days before all subsequent visits

    The absence or presence of skin rash assessed based on physical exam findings including whether it is typical or atypical

    Measured: Week 24

  9. Proportion of patients with fever associated with the underlying disease during 24 weeks of treatment

    Absence of fever associated with the underlying disease during the 7 days preceding the visit day visit was assessed. Fever is defined as an increase in body temperature ≥38.0 °C

    Measured: Week 24

  10. Proportion of patients who had exacerbations

    Increasing disease activity is defined as the appearance of signs of systemic activity, defined as any of the "major" Yamaguchi M. classification criteria (fever >39°C intermittent for ≥1 week; arthralgias ≥2 weeks; characteristic rash; white blood cells >10,000 in mm3 (>80% granulocytes)), as well as an increase in CRP and/or ferritin levels ≥ 3 times normal.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2024
  2. Study start12 Dec 2023
  3. Primary completion29 May 2025
  4. Study completion10 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06497491
Sponsor's protocol ID
CAN-AOSD-III
Status last verified
Aug 2025
First submitted
5 Jul 2024
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GNR-086 and Ilaris® in people with Still's Disease Adult Onset, run by AO GENERIUM at 17 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06497491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

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