A Phase 3 interventional study of Placebo and Goflikicept in Still Disease, sponsored by R-Pharm International, LLC. Not yet recruiting at 25 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by R-Pharm International, LLC (part of R-Pharm) · Phase 3, Interventional, and Treatment
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
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:
Treatment Period
Eligible patients should be randomized to one of two treatment arms (in a 1:1 ratio):
At the Day 7 assessment:
At the Day 28 assessment, response to therapy is defined as:
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
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
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 52 is close to the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →R-Pharm International, LLC is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Prior use of the following medications:
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:
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:
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:
Laboratory abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: Goflikicept
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
Drug: Placebo
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
Biological: Olokizumab
0.9% Sodium Chloride solution for Injection
solution for subcutaneous injection and intravenous infusion, 40 mg/mL
Also known as: RPH-104, Arcerix
solution for subcutaneous injection and intravenous infusion, 160 mg/mL
Also known as: Artlegia
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
Time frame: Day 7 (low disease activity or remission) and Day 28 (remission)
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
Time frame: 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
Proportion of patients with resolution of fever on Day 3 and Day 7
Time frame: 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
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
Time frame: 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
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
Time frame: 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
Disease Activity Score-28 (DAS28) is calculated to assess inflammatory activity
Time frame: 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
Proportion of patients with absence of typical skin rash during the study
Time frame: 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
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
Time frame: 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
Proportion of patients with absence of sore throat during the study
Time frame: 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
Change in C-reactive protein concentration during the study
Time frame: 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
Change in erythrocyte sedimentation rate (ESR) during the study
Time frame: 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
Change in white blood cell (WBC) count during the study
Time frame: 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
Change in ferritin level during the study
Time frame: 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
Active arthritis is defined as a swollen joint count (SJC) ≥ 1; absence of active arthritis is defined as SJC = 0
Time frame: 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
Number of tender joint count during the study
Time frame: 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
Number of swollen joint count during the study
Time frame: 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
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
Time frame: 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
Proportion of patients with absence of lymphadenopathy during the study
Time frame: 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)
Time (number of days) to normalization of C-reactive protein level (\<10 mg/L)
Time frame: up to Day 252 (week 36)
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)
Time frame: up to Day 252 (week 36)
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)
Time frame: up to Day 252 (week 36)
Time (number of days) to resolution of typical skin rash
Time (number of days) to resolution of typical skin rash
Time frame: up to Day 252 (week 36)
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
Time frame: up to Day 252 (week 36)
Time (number of days) to resolution of sore throat
Time (number of days) to resolution of sore throat
Time frame: up to Day 252 (week 36)
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Proportion of patients who prematurely discontinued study treatment due to adverse events (AEs)
Time frame: 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
Laboratory assessments include complete blood count, blood biochemistry, lipid profile, fibrinogen, ferritin, and urinalysis
Time frame: at screening and up to Day 252 (week 36)
Number of patients with clinically significant vital sign abnormalities
Vital signs include blood pressure (mmHg), heart rate (beats per minute), and respiratory rate (breaths per minute)
Time frame: at screening and up to Day 252 (week 36)
Change from baseline in heart rate assessed by electrocardiography (ECG)
Electrocardiography (ECG) is performed in 12 leads (I, II, III, aVR, aVL, aVF, V1-V6) to assess heart rate
Time frame: 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
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
Time frame: 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
Changes in trough concentrations of goflikicept/olokizumab in the serum
Time frame: 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)
Trough concentration of goflikicept/olokizumab in the serum at steady state (Cmin,ss)
Time frame: 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)
Area under the concentration-time curve of goflikicept/olokizumab at steady state (AUCτ,ss)
Time frame: 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)
Time to reach steady state (Tss)
Time frame: 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
Proportion of patients with binding antibodies (BAb) to goflikicept/olokizumab during the study
Time frame: 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
Proportion of patients with neutralizing antibodies (NAb) to goflikicept/olokizumab during the study
Time frame: 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
Changes in IL-1RA, IL-6, IL-18, calprotectin levels in the serum of study patients
Time frame: 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
Changes in ferritin/glycosylated ferritin levels
Time frame: 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)
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Goflikicept