ClinicalTrials.gov record NCT07625384

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old and older
SexAll
LocationRussia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 3, double‑blind randomized study compares goflikicept with placebo in adults with Still's disease. Patients who do not respond may be switched to goflikicept and then to olokizumab as a second-line therapy. Treatment is given over a period that can range up to 36 weeks, with safety follow-up afterward; total participation can be up to 70 weeks. The study also measures drug levels and immune response.

What it is studying. The study tests the efficacy and safety of goflikicept as a second-line therapy for Still's disease compared with placebo. It also evaluates pharmacokinetics/pharmacodynamics and immunogenicity of goflikicept and olokizumab, and tracks clinical outcomes such as remission, symptom resolution, CRP and flare rates.

What the researchers hope to learn. To evaluate the efficacy and safety profile of goflikicept in patients with Still's disease. To assess pharmacokinetics/pharmacodynamics and immunogenicity of goflikicept and olokizumab. To measure clinical outcomes including remission rates, symptom resolution, inflammatory markers (for example CRP), flare frequency, joint counts, and quality-of-life.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Placebo
Biological
  • Goflikicept
  • Olokizumab

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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:

  • Screening period: up to 4 weeks
  • 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

  • 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

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After up to 4 weeks of screening, participants are randomized to receive goflikicept or placebo (both start with an IV infusion on Day 0, then subcutaneous injections on Day 14 and every 2 weeks). Response is assessed at Day 7 and Day 28; placebo non‑responders may switch to goflikicept, and non‑responders to goflikicept may switch to olokizumab (which begins with an IV dose then continues as subcutaneous injections every 2 weeks). Visits include regular disease assessments and blood tests (for example CRP and other labs), and from Day 28 an attempt to taper glucocorticosteroids is made with the goal of stopping by study end; maximum treatment follow‑up is up to Week 36. After the last dose, participants return for safety follow‑up visits (at 4 and 8 weeks; those who received olokizumab also at 22 weeks).

How the study is structured. Participants are randomized 1:1 to receive goflikicept or matching placebo, in a double‑blind, placebo‑controlled design. Goflikicept is started with an IV dose then continued by subcutaneous injections every two weeks; placebo follows the same schedule. At early on-study assessments, non-responders on placebo switch to goflikicept, and non-responders on goflikicept may switch to olokizumab as second-line therapy; response assessments occur about 7 and 28 days after treatment starts. Regular visits and assessments continue (including lab tests, symptom checks and questionnaires) through the treatment period and safety follow-up; maximum total participation is about 70 weeks. The study starts double-blind, but participants who do not respond at the Day 7 assessment are unblinded so they can be switched to second-line therapy; those who respond stay masked.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Russia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on adult-onset Still's disease

Clinical trials13 trials listed for adult-onset Still's diseaseEvery trial the registry lists for adult-onset Still's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in adult-onset Still's disease researchLatest monthly update: September 2026. Includes: MAS initial treatment. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 18, 2026 (estimated)
Primary completion
Dec 14, 2027 (estimated)
Study completion
Jul 1, 2028 (estimated)
Target enrollment
52 participants (estimated)
Last updated on registry
Jun 4, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
R-Pharm International, LLC

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (25)

Terms used on this page · explanations by MedicalUpdates.ai

primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
Informed Consent Form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Women of childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
investigational product
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Immunosuppressants
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
screening period
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Absolute neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
× ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
double-blind
Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled
A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamics
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
1:1
How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
Treatment Arm
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
Placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
Safety Follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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