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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. května 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Odhadovaný)

52

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Olga Sankova
  • Telefonní číslo: +7 (915) 486-45-25
  • E-mail: sankova@rpharm.ru

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Biologický: Goflikicept
solution for subcutaneous injection and intravenous infusion, 40 mg/mL
Ostatní jména:
  • Arcerix
  • RPH-104
Komparátor placeba: 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
Lék: Placebo
0,9% roztok chloridu sodného pro injekci
Jiný: 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
Biologický: Olokizumab
solution for subcutaneous injection and intravenous infusion, 160 mg/mL
Ostatní jména:
  • Artlegia

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of patients who developed a flare of Still's disease within 24 weeks after randomization
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: up to Day 252 (week 36)
Time (number of days) to resolution of sore throat
up to Day 252 (week 36)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

R-Pharm International, LLC

Vyšetřovatelé

  • Ředitel studie: Mikhail Samsonov, R-Pharm International, LLC

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

18. května 2026

Primární dokončení (Odhadovaný)

14. prosince 2027

Dokončení studie (Odhadovaný)

1. července 2028

Termíny zápisu do studia

První předloženo

19. května 2026

První předloženo, které splnilo kritéria kontroly kvality

28. května 2026

První zveřejněno (Aktuální)

4. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CL04018375

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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