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Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease

28 de mayo de 2026 actualizado por: R-Pharm International, LLC

International Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease

The primary objective of the study is to evaluate the efficacy and safety of goflikicept (GFC) and olokizumab (OKZ) in patients with Still's disease

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This is an international, multicenter, double-blind, randomized, placebo-controlled, Phase III clinical trial to evaluate the efficacy and safety of goflikicept (GFC) administered over 16-36 weeks

Additionally, the study evaluates the pharmacokinetics/pharmacodynamics (PK/PD), immunogenicity, efficacy, and safety of GFC and olokizumab (OKZ) as the second-line therapy

The study includes the following periods:

  1. Screening period: up to 4 weeks

  2. Treatment Period

    Eligible patients should be randomized to one of two treatment arms (in a 1:1 ratio):

    • Active Treatment Arm taking GFC
    • Placebo arm

    At the Day 7 assessment:

    • Responders to therapy are defined as patients who achieve or maintain low disease activity or achieve remission compared to baseline according to DAVID criteria, with the exception of arthritis
    • Non-responders in the placebo arm switch to GFC (Day 0 procedures of GFC therapy). Seven days after the first GFC dose (Day 7 procedures of GFC therapy), the investigator performs a response assessment. Patients who respond to the new therapy continue GFC therapy throughout the treatment period
    • Non-responders on GFC therapy (either after randomization or after switching from placebo to GFC) switch to Olokizumab (OKZ) (at a visit with procedures identical to Day 0). Seven days after the first dose of the second-line therapy (Day 7 procedures), the investigator performs a response assessment. Patients who respond to the new therapy continue OKZ therapy throughout the treatment period

    At the Day 28 assessment, response to therapy is defined as:

    • absence of fever
    • absence of typical skin rash
    • C-reactive protein (CRP) ≤ 10 mg/L
    • PtGA < 5 cm
    • absence of arthritis

    Starting from Day 28, patients who have responded have a gradual reduction of the glucocorticosteroid (GCS) dose, with the goal of achieving inactive disease without GCS by the end of the study. In this case, the duration of participation is determined by the baseline GCS dose

    The final visit for patients completing the maximum treatment period is the Week 36 visit

  3. Safety Follow-up Period (Weeks 8 / 22)

During the safety follow-up period, patients are required to visit the clinical center for assessments at 4 and 8 weeks after the last dose of study treatment (for patients who received at least one dose of OKZ - at 4, 8, and 22 weeks), after which their participation in the study will be considered complete

The maximum possible duration of study participation for each patient is 70 weeks

Tipo de estudio

Intervencionista

Inscripción (Estimado)

52

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Olga Sankova
  • Número de teléfono: +7 (915) 486-45-25
  • Correo electrónico: sankova@rpharm.ru

Ubicaciones de estudio

  • Rusia
      • Izhevsk, Rusia, 426009
        • Republic Clinical and Diagnostic Center of the Ministry of Health of the Udmurt Republic
        • Contacto:
      • Kazan', Rusia, 420097
        • "Vashe Zdorovie" Research Medical Complex, LLC
        • Contacto:
          • Svetlana Yakupova
          • Número de teléfono: 8 (843) 537 93 93
          • Correo electrónico: YakupovaSP@mail.ru
      • Korolyov, Rusia, 141060
        • Family Clinic No. 4, LLC
        • Contacto:
          • Nino Mosesova
          • Número de teléfono: +7 (495) 859-42-19
          • Correo electrónico: nino1999@mail.ru
      • Moscow, Rusia, 105554
        • Limited Liability Company "OLLA-MED"
        • Contacto:
          • Daria Kusevich
          • Número de teléfono: +7 495 105 99 05
          • Correo electrónico: ctd@ollamed.ru
      • Moscow, Rusia, 111123
        • State Budgetary Healthcare Institution "A.S. Loginov Moscow Clinical Scientific Center of the Moscow Department of Healthcare"
        • Contacto:
          • Galina Lukina
          • Número de teléfono: +7 (495) 304-30-39
          • Correo electrónico: gvl3@yandex.ru
      • Moscow, Rusia, 115522
        • V.A. Nasonova Research Institute of Rheumatology (Federal State Budgetary Scientific Institution)
        • Contacto:
      • Moscow, Rusia, 117321
        • Limited Liability Company "Firm ORIS"
        • Contacto:
      • Moscow, Rusia, 119049
        • State Budgetary Healthcare Institution of the City of Moscow "N.I. Pirogov City Clinical Hospital No. 1 of the Moscow Department of Healthcare"
        • Contacto:
          • Alesya Klimenko
          • Número de teléfono: +7 (499) 764-50-02
          • Correo electrónico: aaklimenko@yandex.ru
      • Moscow, Rusia, 119435
        • I.M. Sechenov First Moscow State Medical University, University Clinical Hospital No. 3, E.M. Tareev Clinic of Rheumatology, Nephrology and Occupational Pathology
        • Contacto:
          • Sergey Moiseev
          • Número de teléfono: +7 (499) 450-88-89
          • Correo electrónico: avt420034@yahoo.com
      • Moscow, Rusia, 129226
        • Russian Gerontology Clinical Research Center (RGNC) of Pirogov Russian National Research Medical University
        • Contacto:
      • Novosibirsk, Rusia, 630099
        • "Zdorovaya Semya" Medical Center
        • Contacto:
      • Novosibirsk, Rusia, 630117
        • Federal Research Center "Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences"
        • Contacto:
          • Maxim Korolev
          • Número de teléfono: +7 (383) 333-64-09
          • Correo electrónico: kormax@bk.ru
      • Omsk, Rusia, 644111
        • Budgetary Healthcare Institution of the Omsk Region "Regional Clinical Hospital"
        • Contacto:
          • Tatiana Kropotina
          • Número de teléfono: +7 (3812) 23-26-74
          • Correo electrónico: kropotina@list.ru
      • Orenburg, Rusia, 460018
        • State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital named after V.I. Voynov"
        • Contacto:
      • Petrozavodsk, Rusia, 185000
        • State Budgetary Healthcare Institution "V.A. Baranov Republican Hospital"
        • Contacto:
      • Saint Petersburg, Rusia, 191025
        • Limited Liability Company "Medical Technologies"
        • Contacto:
      • Saint Petersburg, Rusia, 194214
        • Interleukin LLC
        • Contacto:
          • Alexey Maslyansky
          • Número de teléfono: +78126022501
          • Correo electrónico: esc_4@mail.ru
      • Saint Petersburg, Rusia, 194291
        • State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
        • Contacto:
          • Elena Ilivanova
          • Número de teléfono: 8 800 301-47-47
          • Correo electrónico: rheum_lokb@mail.ru
      • Saint Petersburg, Rusia, 196066
        • Limited Liability Company "Medical-Sanitary Unit No. 157" (MSU No. 157)
        • Contacto:
          • Vadim Mazurov
          • Número de teléfono: +7 (812) 415-37-00
          • Correo electrónico: maz.nwgmu@yandex.ru
      • Saratov, Rusia, 410053
        • State Healthcare Institution "Regional Clinical Hospital" of Saratov
        • Contacto:
          • Natalya Nikitina
          • Número de teléfono: +7 (8452) 491640
          • Correo electrónico: nikina02@yandex.ru
      • Smolensk, Rusia, 214025
        • Smolensk Regional Rheumatology Center at the "RZD-Medicine" Clinical Hospital (Private Healthcare Institution)
        • Contacto:
      • Tomsk, Rusia, 634050
        • Siberian State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)
        • Contacto:
          • Larisa Eliseeva
          • Número de teléfono: +7 (3822) 53-05-81
          • Correo electrónico: eliseevav@mail.ru
      • Ufa, Rusia, 450005
        • State Budgetary Healthcare Institution "G.G. Kuvatov Republican Clinical Hospital"
        • Contacto:
          • Gulshat Fatkhullina
          • Número de teléfono: +7 (347) 246-33-30
          • Correo electrónico: fgulshatf76@mail.ru
      • Volgograd, Rusia, 400117
        • State Healthcare Institution "City Clinical Emergency Hospital No. 25"
        • Contacto:
          • Lyudmila Shilova
          • Número de teléfono: +7 (8442) 58-16-61
          • Correo electrónico: ludshilova@mail.ru
      • Yaroslavl, Rusia, 150047
        • Yaroslavl State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)
        • Contacto:
          • Natalia Lapkina
          • Número de teléfono: +7 (4852) 20-87-08
          • Correo electrónico: lanaal@rambler.ru

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
  2. Confirmed diagnosis of Adult-Onset Still's Disease (AOSD) based on the Yamaguchi M. diagnostic criteria
  3. Patient with active disease or low disease activity per DAVID criteria
  4. In case of current corticosteroid (CS) use, doses must be stable for at least 2 weeks prior to Day 0. The maximum allowed dose of CS is 1 mg/kg/day, up to 60 mg/day (prednisolone equivalent)
  5. In case of current nonsteroidal anti-inflammatory drugs (NSAID) use, dose of NSAIDs must be stable for at least 2 weeks prior to Day 0
  6. In case of current methotrexate (MTX) use, the dose of MTX must be stable for at least 4 weeks prior to Day 0. The maximum allowed dose is 30 mg/week. In case of prior MTX discontinuation, it must be performed at least 4 weeks before Day 0
  7. Patient's ability and willingness, in the reasonable opinion of the investigator, to attend the clinical center for all scheduled visits, perform study procedures, and comply with protocol requirements, including consent to receive subcutaneous injections by qualified personnel
  8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant (excluding women who are post-menopausal, defined retrospectively as 12 months of natural amenorrhea with appropriate clinical status, e.g., age-appropriate), must agree to use highly effective methods of contraception throughout the study, starting from the signing of the ICF until at least 8 weeks after the last dose of study treatment; and must have a negative pregnancy test (serum human chorionic gonadotropin, hCG)
  9. Sexually active male participants must agree to use highly effective methods of contraception throughout the study, starting from the signing of the ICF until at least 8 weeks after the last dose of study treatment

Exclusion Criteria:

  1. Hypersensitivity to the active and/or inactive ingredients of the investigational product

  2. Prior use of the following medications:

    • Rilonacept - less than 6 weeks prior to Day 0
    • Canakinumab - less than 20 weeks prior to Day 0
    • Anakinra - less than 1 week prior to Day 0
    • TNF-alpha inhibitors: etanercept less than 2 weeks, adalimumab, certolizumab, or golimumab less than 10 weeks prior to Day 0
    • IL-6 inhibitors: olokizumab - less than 20 weeks, tocilizumab - less than 16 weeks, or sarilumab less than 8 weeks prior to Day 0
    • Janus kinase (JAK) inhibitors - less than 1 week prior to Day 0
    • Immunosuppressants (azathioprine less than 3 days, cyclosporine less than 1 week, mycophenolate mofetil less than 1 week, tacrolimus less than 10 days, mercaptopurine less than 2 days, etc., except for methotrexate) - less than 5 half-lives prior to Day 0
    • Leflunomide - less than 10 weeks prior to Day 0
    • Corticosteroid pulse therapy (e.g., intravenous methylprednisolone 250-1000 mg/day or equivalent dose of dexamethasone for 3 days) - less than 4 weeks (from the completion of pulse therapy) prior to Day 0
    • Intravenous immunoglobulin (IVIG) - less than 4 weeks prior to Day 0
    • Other biologic drug with immunosuppressive effects - less than 5 half-lives prior to Day 0
  3. Use of live-attenuated vaccines within less than 3 months prior to Day 0 (start of the treatment period in the study) and/or anticipated need for such vaccination within 3 months after completion of the investigational therapy. Live-attenuated vaccines include vaccines against measles, rubella, mumps, varicella, rotavirus, influenza (intranasal), yellow fever, poliomyelitis (oral polio vaccine), as well as vaccines against tuberculosis (BCG), typhoid (oral typhoid vaccine), and epidemic typhus. Immunocompetent household members of the patient must refrain from receiving oral polio vaccine during the patient's participation in the study

  4. Presence of conditions or signs that, in the investigator's opinion, indicate impaired immune response and/or significantly increase the risk associated with immunomodulatory therapy, including but not limited to:

    • Active bacterial, fungal, viral, or protozoal infection at the start of the screening period
    • Opportunistic infections and/or Kaposi's sarcoma at the start of screening
    • Chronic bacterial, fungal, or viral infection requiring systemic parenteral therapy at the start of screening
    • HIV infection, viral hepatitis B or C, or syphilis (patients with hepatitis B and/or C who have received antiviral therapy and have had undetectable viral load for at least 6 months may be eligible, subject to confirmation by an appropriate specialist)

  5. History of active tuberculosis (TB); suspected or confirmed active tuberculosis at present; or signs of active tuberculosis, including chest computed tomography (CT) or chest X-ray findings consistent with pulmonary tuberculosis during screening; or presence of risk factors for tuberculosis, including but not limited to:

    • Living conditions associated with increased risk of exposure (e.g., correctional facilities, homeless shelters) within 1 year prior to randomization
    • Healthcare workers with unprotected exposure to patients at high risk of TB or with TB within 1 year prior to randomization
    • Close contact (i.e., prolonged cohabitation for days or weeks, not minutes or hours) with a person with active tuberculosis within 1 year prior to randomization

  6. History of latent TB without adequate treatment, regardless of screening QuantiFERON-TB/T-SPOT.TB results, or a positive QuantiFERON-TB/T-SPOT.TB result at screening. Such patients may be re-screened and enrolled if all of the following are met:

    • Active TB is ruled out by a certified TB specialist
    • The patient has completed at least 30 days of prophylactic anti-TB therapy for LTBI prior to screening, using country-recommended regimens
    • The patient agrees to complete the full course of LTBI treatment
  7. Any other significant comorbidities (cardiovascular, neurological, endocrine, renal, gastrointestinal, hepatic, coagulation disorders, other systemic rheumatic diseases, psychiatric disorders, etc.) that, in the investigator's judgment, may adversely affect participation, patient safety, or study results
  8. History of organ transplantation or need for transplantation at screening
  9. Malignancy during screening or within 5 years prior, except adequately treated non-metastatic basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of any type after complete resection
  10. Pregnancy or breastfeeding
  11. Alcohol or substance abuse, in the investigator's opinion
  12. Severe renal impairment: creatinine clearance (Cockcroft-Gault) < 30 mL/min

  13. Laboratory abnormalities:

    • Absolute neutrophil count < 1.5 × 10^9/L
    • Leukocytes < 3.5 × 10^9/L
    • Platelets < 100 × 10^9/L
    • Hemoglobin ≤ 80 g/L
    • HbA1c ≥ 8%
    • ALT and/or AST > 8 × ULN
    • AST and/or ALT > 3 × ULN with bilirubin > 1.5 × ULN
    • Total bilirubin > 2 × ULN (except confirmed Gilbert's syndrome)
  14. Participation in another clinical trial at screening or use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to Visit 1 (start of treatment period)
  15. Presence or suspicion of macrophage activation syndrome (MAS) at screening. MAS criteria includes persistent fever, splenomegaly, elevated or rising serum ferritin levels, cytopenia, abnormal liver function tests, intravascular activation of coagulation, and elevated or rising serum triglyceride levels
  16. Diagnosis of MAS within 2 months prior to Day 0
  17. Prior participation in this clinical study, provided the patient received at least one dose of the investigational product

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Goflikicept
Goflikicept is administered at a dose of 320 mg intravenously (IV) infusion on Day 0, followed by 160 mg subcutaneously (SC) on Day 14 and subsequently 160 mg SC every 2 weeks
Biológico: Goflikicept
solution for subcutaneous injection and intravenous infusion, 40 mg/mL
Otros nombres:
  • Arcerix
  • RPH-104
Comparador de placebos: Placebo
Placebo is administered at a dose of 320 mg intravenously (IV) infusion on Day 0, followed by 160 mg subcutaneously (SC) on Day 14 and subsequently 160 mg SC every 2 weeks
Droga: Placebo
Solución inyectable de cloruro de sodio al 0,9 %
Otro: Olokizumab
Participants who do not respond to treatment with Goflikicept (including those switched from placebo) are transitioned to second-line therapy with Olokizumab. Olokizumab is administered at 128 mg intravenously at the initiation visit, followed by response assessment at Day 7. Participants who respond to treatment continue Olokizumab at a dose of 64 mg subcutaneously every 2 weeks during the treatment period
Biológico: Olokizumab
solution for subcutaneous injection and intravenous infusion, 160 mg/mL
Otros nombres:
  • Artlegia

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of patients who achieved and maintained low disease activity or remission according to DAVID criteria at Day 7 (excluding the arthritis criterion) and achieved DAVID remission criteria at Day 28
Periodo de tiempo: Day 7 (low disease activity or remission) and Day 28 (remission)

Low disease activity according to DAVID criteria is defined as the absence of fever and the presence of only one of the following criteria:

  • typical skin rash
  • arthritis
  • C-reactive protein (CRP) level > 10 mg/L
  • Patient's global assessment of arthritis (PtGA) ≥ 5 cm

Remission according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA < 5 cm
Day 7 (low disease activity or remission) and Day 28 (remission)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of patients who developed a flare of Still's disease within 24 weeks after randomization
Periodo de tiempo: at screening, Day 28 (week 4), and every 4 weeks up to Day 168 (week 24)

Flare is defined as the occurrence of criteria consistent with low disease activity starting from Day 28

Low disease activity according to DAVID criteria is defined as the absence of fever and the presence of only one of the following criteria:

  • typical skin rash
  • arthritis
  • C-reactive protein (CRP) level > 10 mg/L
  • Patient's global assessment of arthritis (PtGA) ≥ 5 cm
at screening, Day 28 (week 4), and every 4 weeks up to Day 168 (week 24)
Proportion of patients with resolution of fever on Day 3 and Day 7
Periodo de tiempo: Day 3 and Day 7
Proportion of patients with resolution of fever on Day 3 and Day 7
Day 3 and Day 7
Proportion of patients who achieved inactive disease while on low-dose glucocorticosteroids (0.1 mg/kg/day) during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Inactive disease according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA < 5 cm
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients who achieved inactive disease without glucocorticosteroids during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Inactive disease according to DAVID criteria is defined as the absence of fever, typical skin rash, arthritis, CRP level ≤ 10 mg/L and PtGA < 5 cm
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with Disease Activity Score-28 (DAS28) <2.6 during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Disease Activity Score-28 (DAS28) is calculated to assess inflammatory activity
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with absence of typical skin rash during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with absence of typical skin rash during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with PtGA < 5 during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Patient's Global Assessment (PtGA) is assessed using a 10-cm visual analog scale (VAS), with 0 representing very good condition and 10 representing very poor condition
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with absence of sore throat during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with absence of sore throat during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in C-reactive protein concentration during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in C-reactive protein concentration during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in erythrocyte sedimentation rate (ESR) during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in erythrocyte sedimentation rate (ESR) during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in white blood cell (WBC) count during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in white blood cell (WBC) count during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in ferritin level during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in ferritin level during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Number of joints with active arthritis during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Active arthritis is defined as a swollen joint count (SJC) ≥ 1; absence of active arthritis is defined as SJC = 0
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Number of tender joint count during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Number of tender joint count during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Number of swollen joint count during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Number of swollen joint count during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Change in patients' quality of life during the study based on the SF-36 questionnaire results
Periodo de tiempo: at screening, on Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
The 36-Item Short Form Health Survey version 1.0 (SF-36 v1.0) includes 8 domains calculated as weighted sums of questionnaire items: vitality, physical functioning, bodily pain, general health perception, role limitations due to physical health, role limitations due to emotional problems, social functioning, and mental health. Each domain score is transformed to a 0-100 scale, where higher score indicates better health status and lower functional impairment
at screening, on Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with absence of lymphadenopathy during the study
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with absence of lymphadenopathy during the study
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Time (number of days) to normalization of C-reactive protein level (<10 mg/L)
Periodo de tiempo: up to Day 252 (week 36)
Time (number of days) to normalization of C-reactive protein level (<10 mg/L)
up to Day 252 (week 36)
Time (number of days) to normalization of white blood cell count (according to the laboratory reference range)
Periodo de tiempo: up to Day 252 (week 36)
Time (number of days) to normalization of white blood cell count (according to the laboratory reference range)
up to Day 252 (week 36)
Time (number of days) to normalization of ferritin level (according to the laboratory reference range)
Periodo de tiempo: up to Day 252 (week 36)
Time (number of days) to normalization of ferritin level (according to the laboratory reference range)
up to Day 252 (week 36)
Time (number of days) to resolution of typical skin rash
Periodo de tiempo: up to Day 252 (week 36)
Time (number of days) to resolution of typical skin rash
up to Day 252 (week 36)
Time (number of days) to resolution of active arthritis
Periodo de tiempo: up to Day 252 (week 36)
Active arthritis is defined as a swollen joint count (SJC) ≥ 1; absence of active arthritis is defined as SJC = 0
up to Day 252 (week 36)
Time (number of days) to resolution of sore throat
Periodo de tiempo: up to Day 252 (week 36)
Time (number of days) to resolution of sore throat
up to Day 252 (week 36)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Periodo de tiempo: Up to Day 252 (Week 36), with follow-up visits at Weeks 4, 8, and 22 (Olokizumab group)
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Up to Day 252 (Week 36), with follow-up visits at Weeks 4, 8, and 22 (Olokizumab group)
Number of patients with clinically significant laboratory abnormalities
Periodo de tiempo: at screening and up to Day 252 (week 36)
Laboratory assessments include complete blood count, blood biochemistry, lipid profile, fibrinogen, ferritin, and urinalysis
at screening and up to Day 252 (week 36)
Number of patients with clinically significant vital sign abnormalities
Periodo de tiempo: at screening and up to Day 252 (week 36)
Vital signs include blood pressure (mmHg), heart rate (beats per minute), and respiratory rate (breaths per minute)
at screening and up to Day 252 (week 36)
Change from baseline in heart rate assessed by electrocardiography (ECG)
Periodo de tiempo: at screening, on Day 28 (week 4), Day 112 (week 16), and every 4 weeks up to Day 252 (week 36)
Electrocardiography (ECG) is performed in 12 leads (I, II, III, aVR, aVL, aVF, V1-V6) to assess heart rate
at screening, on Day 28 (week 4), Day 112 (week 16), and every 4 weeks up to Day 252 (week 36)
Incidence, severity, nature, and outcomes of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interests (AESIs) during the study
Periodo de tiempo: Up to Day 252 (Week 36), with follow-up visits at Weeks 4, 8, and 22 (Olokizumab group)

Adverse event severity is graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0

Adverse events of special interest (AESIs) include:

  • Infections (including serious infections), including tuberculosis and opportunistic infections
  • Malignancies
  • Increased blood lipid levels (i.e., hypercholesterolemia, increased blood cholesterol, increased blood triglycerides, hypertriglyceridemia, and increased low-density lipoprotein)
  • Systemic administration-related reactions and hypersensitivity reactions
  • Neutropenia, thrombocytopenia, and leukopenia
  • Drug-induced liver injury and increased liver enzymes
  • Injection site reactions
Up to Day 252 (Week 36), with follow-up visits at Weeks 4, 8, and 22 (Olokizumab group)
Changes in trough concentrations of goflikicept/olokizumab in the serum
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Changes in trough concentrations of goflikicept/olokizumab in the serum
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Trough concentration of goflikicept/olokizumab in the serum at steady state (Cmin,ss)
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Trough concentration of goflikicept/olokizumab in the serum at steady state (Cmin,ss)
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Area under the concentration-time curve of goflikicept/olokizumab at steady state (AUCτ,ss)
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Area under the concentration-time curve of goflikicept/olokizumab at steady state (AUCτ,ss)
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Time to reach steady state (Tss)
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Time to reach steady state (Tss)
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Proportion of patients with binding antibodies (BAb) to goflikicept/olokizumab during the study
Periodo de tiempo: at screening, on Day 28 (week 4), Day 56 (week 8), Day 84 (week 12) and every 4 weeks up to Day 252 (week 36)
Proportion of patients with binding antibodies (BAb) to goflikicept/olokizumab during the study
at screening, on Day 28 (week 4), Day 56 (week 8), Day 84 (week 12) and every 4 weeks up to Day 252 (week 36)
Proportion of patients with neutralizing antibodies (NAb) to goflikicept/olokizumab during the study
Periodo de tiempo: at screening, on Day 28 (week 4), Day 56 (week 8), Day 84 (week 12) and every 4 weeks up to Day 252 (week 36)
Proportion of patients with neutralizing antibodies (NAb) to goflikicept/olokizumab during the study
at screening, on Day 28 (week 4), Day 56 (week 8), Day 84 (week 12) and every 4 weeks up to Day 252 (week 36)
Changes in IL-1RA, IL-6, IL-18, calprotectin levels in the serum of study patients
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Changes in IL-1RA, IL-6, IL-18, calprotectin levels in the serum of study patients
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Changes in ferritin/glycosylated ferritin levels
Periodo de tiempo: at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)
Changes in ferritin/glycosylated ferritin levels
at screening, on Day 7 (week 1), Day 14 (week 2), Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

R-Pharm International, LLC

Investigadores

  • Director de estudio: Mikhail Samsonov, R-Pharm International, LLC

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

18 de mayo de 2026

Finalización primaria (Estimado)

14 de diciembre de 2027

Finalización del estudio (Estimado)

1 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

19 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CL04018375

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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