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Still DiseasePhase 3NCT07625384

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

A Phase 3 study testing Goflikicept and Olokizumab in people with Still Disease, run by R-Pharm International, LLC at 25 sites in Russia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Still Disease
What is being tested?
Goflikicept and Olokizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
25 sitesRussia
Study dates
18 May 2026to 1 Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
  • Confirmed diagnosis of Adult-Onset Still's Disease (AOSD) based on the Yamaguchi M. diagnostic criteria
  • Patient with active disease or low disease activity per DAVID criteria
  • 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)
  • 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
  • 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
Show all 9Show fewer
  • 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
  • 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)
  • 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

Who cannot join

  • Hypersensitivity to the active and/or inactive ingredients of the investigational product
  • 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
Show all 46Show fewer
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • History of organ transplantation or need for transplantation at screening
  • 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
  • Pregnancy or breastfeeding
  • Alcohol or substance abuse, in the investigator's opinion
  • Severe renal impairment: creatinine clearance (Cockcroft-Gault) < 30 mL/min
  • 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)
  • 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)
  • 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
  • Diagnosis of MAS within 2 months prior to Day 0
  • Prior participation in this clinical study, provided the patient received at least one dose of the investigational product

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olga Sankova contact

+7 (915) 486-45-25

sankova@rpharm.ru

25 sites in 1 country

Russia25 sites

  • Republic Clinical and Diagnostic Center of the Ministry of Health of the Udmurt Republic

    Izhevsk, 426009

    Larisa Ivanova, (3412) 682600, loraivanova7@mail.ru

  • "Vashe Zdorovie" Research Medical Complex, LLC

    Kazan', 420097

    Svetlana Yakupova, 8 (843) 537 93 93, YakupovaSP@mail.ru

  • Family Clinic No. 4, LLC

    Korolyov, 141060

    Nino Mosesova, +7 (495) 859-42-19, nino1999@mail.ru

  • Limited Liability Company "OLLA-MED"

    Moscow, 105554

    Daria Kusevich, +7 495 105 99 05, ctd@ollamed.ru

  • State Budgetary Healthcare Institution "A.S. Loginov Moscow Clinical Scientific Center of the Moscow Department of Healthcare"

    Moscow, 111123

    Galina Lukina, +7 (495) 304-30-39, gvl3@yandex.ru

  • V.A. Nasonova Research Institute of Rheumatology (Federal State Budgetary Scientific Institution)

    Moscow, 115522

    Anna Torgashina, +7 495 109-29-10, anna.torgashina@gmail.com

  • Limited Liability Company "Firm ORIS"

    Moscow, 117321

    Elena Shchegoleva, +7 (495) 228-77-88, shchegoleva09@gmail.com

  • State Budgetary Healthcare Institution of the City of Moscow "N.I. Pirogov City Clinical Hospital No. 1 of the Moscow Department of Healthcare"

    Moscow, 119049

    Alesya Klimenko, +7 (499) 764-50-02, aaklimenko@yandex.ru

  • I.M. Sechenov First Moscow State Medical University, University Clinical Hospital No. 3, E.M. Tareev Clinic of Rheumatology, Nephrology and Occupational Pathology

    Moscow, 119435

    Sergey Moiseev, +7 (499) 450-88-89, avt420034@yahoo.com

  • Russian Gerontology Clinical Research Center (RGNC) of Pirogov Russian National Research Medical University

    Moscow, 129226

    Alexey Meshkov, +7 (499) 187-29-96, alexeymeshkov@mail.ru

  • "Zdorovaya Semya" Medical Center

    Novosibirsk, 630099

    Elena Zonova, +7 (383) 383-00-68, Elena_zonova@list.ru

  • Federal Research Center "Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences"

    Novosibirsk, 630117

    Maxim Korolev, +7 (383) 333-64-09, kormax@bk.ru

  • Budgetary Healthcare Institution of the Omsk Region "Regional Clinical Hospital"

    Omsk, 644111

    Tatiana Kropotina, +7 (3812) 23-26-74, kropotina@list.ru

  • State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital named after V.I. Voynov"

    Orenburg, 460018

    Olga Bugrova, +7 (3532) 31-47-55, ov.bugrova@yandex.ru

  • State Budgetary Healthcare Institution "V.A. Baranov Republican Hospital"

    Petrozavodsk, 185000

    Irina Marusenko, +79004638475, Imarusenko@yandex.ru

  • Limited Liability Company "Medical Technologies"

    Saint Petersburg, 191025

    Mikhail Kostik, +7 911 120-11-40, kost-mikhail@yandex.ru

  • Interleukin LLC

    Saint Petersburg, 194214

    Alexey Maslyansky, +78126022501, esc_4@mail.ru

  • State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

    Saint Petersburg, 194291

    Elena Ilivanova, 8 800 301-47-47, rheum_lokb@mail.ru

  • Limited Liability Company "Medical-Sanitary Unit No. 157" (MSU No. 157)

    Saint Petersburg, 196066

    Vadim Mazurov, +7 (812) 415-37-00, maz.nwgmu@yandex.ru

  • State Healthcare Institution "Regional Clinical Hospital" of Saratov

    Saratov, 410053

    Natalya Nikitina, +7 (8452) 491640, nikina02@yandex.ru

  • Smolensk Regional Rheumatology Center at the "RZD-Medicine" Clinical Hospital (Private Healthcare Institution)

    Smolensk, 214025

    Diana Krechikova, 8 (4812) 24-50-60, d.krechikova@gmail.com

  • Siberian State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)

    Tomsk, 634050

    Larisa Eliseeva, +7 (3822) 53-05-81, eliseevav@mail.ru

  • State Budgetary Healthcare Institution "G.G. Kuvatov Republican Clinical Hospital"

    Ufa, 450005

    Gulshat Fatkhullina, +7 (347) 246-33-30, fgulshatf76@mail.ru

  • State Healthcare Institution "City Clinical Emergency Hospital No. 25"

    Volgograd, 400117

    Lyudmila Shilova, +7 (8442) 58-16-61, ludshilova@mail.ru

  • Yaroslavl State Medical University (Federal State Budgetary Educational Institution of Higher Education of the Ministry of Health of the Russian Federation)

    Yaroslavl, 150047

    Natalia Lapkina, +7 (4852) 20-87-08, lanaal@rambler.ru

Other trials in Russia

About this study

Official title: 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

Read the detailed description

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
  1. 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

Conditions
Still Disease
Being tested
Placebo, Goflikicept, Olokizumab
Keywords
Still's Disease, Goflikicept, RPH-104, Olokizumab
Medical subject headings
Arthritis, Juvenile

What participants receive

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

  • PlaceboDrug

    0.9% Sodium Chloride solution for Injection

  • GoflikiceptBiological

    Also called RPH-104, Arcerix

    solution for subcutaneous injection and intravenous infusion, 40 mg/mL

  • OlokizumabBiological

    Also called Artlegia

    solution for subcutaneous injection and intravenous infusion, 160 mg/mL

Study groups in NCT07625384
Study groupRoleWhat they receive
GoflikiceptExperimentalGoflikicept 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
Receives: Biological: Goflikicept
PlaceboPlacebo comparatorPlacebo 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
Receives: Drug: Placebo
OlokizumabOtherParticipants 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
Receives: Biological: Olokizumab

What is being measured

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

  1. 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

    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

    Measured: Day 7 (low disease activity or remission) and Day 28 (remission)

Secondary outcomes (23)

  1. Proportion of patients who developed a flare of Still's disease within 24 weeks after randomization

    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

    Measured: at screening, Day 28 (week 4), and every 4 weeks up to Day 168 (week 24)

  2. Proportion of patients with resolution of fever on Day 3 and Day 7

    Proportion of patients with resolution of fever on Day 3 and Day 7

    Measured: Day 3 and Day 7

  3. Proportion of patients who achieved inactive disease while on low-dose glucocorticosteroids (0.1 mg/kg/day) during the study

    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

    Measured: 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)

  4. Proportion of patients who achieved inactive disease without glucocorticosteroids during the study

    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

    Measured: 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)

  5. Proportion of patients with Disease Activity Score-28 (DAS28) <2.6 during the study

    Disease Activity Score-28 (DAS28) is calculated to assess inflammatory activity

    Measured: 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)

  6. Proportion of patients with absence of typical skin rash during the study

    Proportion of patients with absence of typical skin rash during the study

    Measured: 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)

  7. Proportion of patients with PtGA < 5 during the study

    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

    Measured: 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)

  8. Proportion of patients with absence of sore throat during the study

    Proportion of patients with absence of sore throat during the study

    Measured: 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)

  9. Change in C-reactive protein concentration during the study

    Change in C-reactive protein concentration during the study

    Measured: 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)

  10. Change in erythrocyte sedimentation rate (ESR) during the study

    Change in erythrocyte sedimentation rate (ESR) during the study

    Measured: 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)

  11. Change in white blood cell (WBC) count during the study

    Change in white blood cell (WBC) count during the study

    Measured: 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)

  12. Change in ferritin level during the study

    Change in ferritin level during the study

    Measured: 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)

  13. Number of joints with active arthritis during the study

    Active arthritis is defined as a swollen joint count (SJC) ≥ 1; absence of active arthritis is defined as SJC = 0

    Measured: 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)

  14. Number of tender joint count during the study

    Number of tender joint count during the study

    Measured: 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)

  15. Number of swollen joint count during the study

    Number of swollen joint count during the study

    Measured: 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)

  16. Change in patients' quality of life during the study based on the SF-36 questionnaire results

    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

    Measured: at screening, on Day 28 (week 4), and every 4 weeks up to Day 252 (week 36)

  17. Proportion of patients with absence of lymphadenopathy during the study

    Proportion of patients with absence of lymphadenopathy during the study

    Measured: 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)

  18. Time (number of days) to normalization of C-reactive protein level (<10 mg/L)

    Time (number of days) to normalization of C-reactive protein level (<10 mg/L)

    Measured: up to Day 252 (week 36)

  19. Time (number of days) to normalization of white blood cell count (according to the laboratory reference range)

    Time (number of days) to normalization of white blood cell count (according to the laboratory reference range)

    Measured: up to Day 252 (week 36)

  20. Time (number of days) to normalization of ferritin level (according to the laboratory reference range)

    Time (number of days) to normalization of ferritin level (according to the laboratory reference range)

    Measured: up to Day 252 (week 36)

  21. Time (number of days) to resolution of typical skin rash

    Time (number of days) to resolution of typical skin rash

    Measured: up to Day 252 (week 36)

  22. Time (number of days) to resolution of active arthritis

    Active arthritis is defined as a swollen joint count (SJC) ≥ 1; absence of active arthritis is defined as SJC = 0

    Measured: up to Day 252 (week 36)

  23. Time (number of days) to resolution of sore throat

    Time (number of days) to resolution of sore throat

    Measured: up to Day 252 (week 36)

Timeline

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

  1. First posted4 Jun 2026
  2. Study start18 May 2026 (estimated)
  3. Primary completion14 Dec 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07625384
Sponsor's protocol ID
CL04018375
Status last verified
May 2026
First submitted
19 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Goflikicept and Olokizumab in people with Still Disease, run by R-Pharm International, LLC at 25 sites in Russia.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Olga Sankova (+7 (915) 486-45-25, sankova@rpharm.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 7 (low disease activity or remission) and Day 28 (remission)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07625384.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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