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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 maio de 2026 atualizado 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

52

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Olga Sankova
  • Número de telefone: +7 (915) 486-45-25
  • E-mail: sankova@rpharm.ru

Locais de estudo

  • Rússia
      • Izhevsk, Rússia, 426009
        • Republic Clinical and Diagnostic Center of the Ministry of Health of the Udmurt Republic
        • Contato:
      • Kazan', Rússia, 420097
        • "Vashe Zdorovie" Research Medical Complex, LLC
        • Contato:
      • Korolyov, Rússia, 141060
        • Family Clinic No. 4, LLC
        • Contato:
          • Nino Mosesova
          • Número de telefone: +7 (495) 859-42-19
          • E-mail: nino1999@mail.ru
      • Moscow, Rússia, 105554
        • Limited Liability Company "OLLA-MED"
        • Contato:
          • Daria Kusevich
          • Número de telefone: +7 495 105 99 05
          • E-mail: ctd@ollamed.ru
      • Moscow, Rússia, 111123
        • State Budgetary Healthcare Institution "A.S. Loginov Moscow Clinical Scientific Center of the Moscow Department of Healthcare"
        • Contato:
          • Galina Lukina
          • Número de telefone: +7 (495) 304-30-39
          • E-mail: gvl3@yandex.ru
      • Moscow, Rússia, 115522
        • V.A. Nasonova Research Institute of Rheumatology (Federal State Budgetary Scientific Institution)
        • Contato:
      • Moscow, Rússia, 117321
        • Limited Liability Company "Firm ORIS"
        • Contato:
      • Moscow, Rússia, 119049
        • State Budgetary Healthcare Institution of the City of Moscow "N.I. Pirogov City Clinical Hospital No. 1 of the Moscow Department of Healthcare"
        • Contato:
      • Moscow, Rússia, 119435
        • I.M. Sechenov First Moscow State Medical University, University Clinical Hospital No. 3, E.M. Tareev Clinic of Rheumatology, Nephrology and Occupational Pathology
        • Contato:
      • Moscow, Rússia, 129226
        • Russian Gerontology Clinical Research Center (RGNC) of Pirogov Russian National Research Medical University
        • Contato:
      • Novosibirsk, Rússia, 630099
        • "Zdorovaya Semya" Medical Center
        • Contato:
      • Novosibirsk, Rússia, 630117
        • Federal Research Center "Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences"
        • Contato:
          • Maxim Korolev
          • Número de telefone: +7 (383) 333-64-09
          • E-mail: kormax@bk.ru
      • Omsk, Rússia, 644111
        • Budgetary Healthcare Institution of the Omsk Region "Regional Clinical Hospital"
        • Contato:
          • Tatiana Kropotina
          • Número de telefone: +7 (3812) 23-26-74
          • E-mail: kropotina@list.ru
      • Orenburg, Rússia, 460018
        • State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital named after V.I. Voynov"
        • Contato:
      • Petrozavodsk, Rússia, 185000
        • State Budgetary Healthcare Institution "V.A. Baranov Republican Hospital"
        • Contato:
      • Saint Petersburg, Rússia, 191025
        • Limited Liability Company "Medical Technologies"
        • Contato:
      • Saint Petersburg, Rússia, 194214
        • Interleukin LLC
        • Contato:
          • Alexey Maslyansky
          • Número de telefone: +78126022501
          • E-mail: esc_4@mail.ru
      • Saint Petersburg, Rússia, 194291
        • State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
        • Contato:
      • Saint Petersburg, Rússia, 196066
        • Limited Liability Company "Medical-Sanitary Unit No. 157" (MSU No. 157)
        • Contato:
      • Saratov, Rússia, 410053
        • State Healthcare Institution "Regional Clinical Hospital" of Saratov
        • Contato:
      • Smolensk, Rússia, 214025
        • Smolensk Regional Rheumatology Center at the "RZD-Medicine" Clinical Hospital (Private Healthcare Institution)
        • Contato:
      • Tomsk, Rússia, 634050
        • Siberian State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)
        • Contato:
      • Ufa, Rússia, 450005
        • State Budgetary Healthcare Institution "G.G. Kuvatov Republican Clinical Hospital"
        • Contato:
      • Volgograd, Rússia, 400117
        • State Healthcare Institution "City Clinical Emergency Hospital No. 25"
        • Contato:
      • Yaroslavl, Rússia, 150047
        • Yaroslavl State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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
Outros nomes:
  • Arcérix
  • RPH-104
Comparador de Placebo: 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
Medicamento: Placebo
Solução de cloreto de sódio a 0,9% para injeção
Outro: 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
Outros nomes:
  • Artlégia

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of patients who developed a flare of Still's disease within 24 weeks after randomization
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: up to Day 252 (week 36)
Time (number of days) to resolution of sore throat
up to Day 252 (week 36)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

R-Pharm International, LLC

Investigadores

  • Diretor de estudo: Mikhail Samsonov, R-Pharm International, LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

18 de maio de 2026

Conclusão Primária (Estimado)

14 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de julho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CL04018375

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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