Juvenile Idiopathic ArthritisPhase 2NCT07517575
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
A Phase 2 study testing OKZ q4w in people with Juvenile Idiopathic Arthritis, run by R-Pharm International, LLC at 14 sites in Russia.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- OKZ q4w
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 14 sitesRussia
- Study dates
- 17 Mar 2023to Jun 2030
- Phase
- Phase 2
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study informed consent form voluntarily and independently signed by patient legal representative
- Study assent form voluntarily and independently signed by minor study subject (patient)
- Male or female patients aged ≥12 and <18 years (cohort 1 - subgroup A) or >2 and <12 years (cohort 1 - subgroup B) or >2 and <18 years (cohort 2) at the time of screening initiation and on Day 0
- Body weight at the start of screening and on Day 0 ≥45 kg (cohort 1 - subgroup A) or ≥30 and <45 kg (cohort 1 - subgroup B) or ≥18 and <30 kg (cohort 2)
- A reliable diagnosis of juvenile idiopathic arthritis (JIA) according to the JIA International League of Associations for Rheumatology (ILAR) 1 criteria with onset before the age of 16 years:
- Seropositive or seronegative polyarthritis (pJIA) ≥3 months before screening, or
Show all 11Show fewer
- Systemic JIA (sJIA) for ≥3 months before screening, provided that joint symptoms persist without active systemic manifestations for ≥3 months before screening, or
- Extended oligoarticular JIA (оJIA) ≥3 months before screening
- American College of Radiology (ACR) criteria of active polyarthritis are met: 5 or more active joints at screening and on Day 0
- C-reactive protein (CRP) level on screening or in anamnesis, not associated with alternative causes of increase other than the activity of the underlying disease, ≥6 mg/l
- Intolerance or failure of methotrexate in the dose of ≥15 mg/m^2/week (or less, in a case of documented intolerance of higher doses) for ≥3 months in medical history
Who cannot join
- Prior use of any drug that acts directly on IL-6 or IL-6R
- If methotrexate is administered - any change in dose or in a formulation within 6 weeks prior to Day 0
- Previous therapy with marketed or experimental conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying anti-rheumatic drugs (bDMARDs) within less than 5 elimination half-lives
- Use of oral steroids in the doses above 0.2 mg/kg or 10 mg/day of prednisolone daily, whatever is lower, or a change in dose within 2 weeks prior to Day 0, or use of parenteral or topical steroids within 4 weeks prior to Day 0
- Change in dose of a non-steroidal anti-inflammatory drug (NSAID) within ≤2 weeks prior to Day 0
- Vaccination with live vaccines within 6 weeks before baseline, or planned vaccination with live vaccines during the study and/or within 6 weeks after the last olokizumab administration
Show all 20Show fewer
- Active uveitis at screening or uveitis exacerbation within 24 weeks before screening
- Laboratory abnormalities (creatinine ≥1 mg/dL (88 mM) for children aged 12 or ≥1.2 mg/dL (106 mM) for children aged 13 and older; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 х upper limit normal (ULN); platelets <180,000/mm^3; white blood count (WBC) <4000/mm^3; neutrophils <2000/mm^3; hemoglobin ≤80 g/L
- Exclusion criteria related to past or current infection other than tuberculosis
- Suspected or confirmed current tuberculosis (TB) infection, history of an active or latent TB infection
- Active course of a disease associated with formation of intestinal diverticula, or any other symptomatic gastrointestinal disease that may increase risk of perforation; or a history of diverticulitis or perforation; or concurrent Crohn's disease or ulcerative colitis
- Concurrent heart failure New York Heart Association (NYHA) III or IV functional class
- In patients with diabetes mellitus - HbA1c > 7% within the last 3 months (non-controlled diabetes mellitus)
- Patients with Steinbrocker class IV functional impairment
- Presence of systemic autoimmune or autoinflammatory disease, except JIA, or chronic autoimmune hepatitis or diseases of the primary immunodeficiencies group
- Patients with history of macrophage activation syndrome episodes
- Exclusion criteria related to concurrent diseases and conditions that may increase potential risk related to participation in the study and study drug exposure
- Known hypersensitivity to any component of the study drug
- Pregnant or breast-feeding female participants or planned pregnancy
- Other protocol-defined non-inclusion criteria apply
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Russia14 sites, 14 recruiting
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
Kazan', 420012
- Recruiting
Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"
Moscow, 115522
- Recruiting
State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department" (GBUZ "Morozovskaya DGBK DZM")
Moscow, 119049
- Recruiting
Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, 119435
- Recruiting
Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation
Moscow, 119991
- Recruiting
Limited Liability Company "Healthy Family Medical Center"
Novosibirsk, 630099
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don, 344022
- Recruiting
LLC "Medical Technologies"
Saint Petersburg, 192148
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation
Saratov, 410054
- Recruiting
Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")
Stavropol, 55000
- Recruiting
State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5"
Tolyatti, 445039
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, 450083
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "Voronezh State Medical University named after N.N. Burdenko" of the Ministry of Health of the Russian Federation
Voronezh, 394036
- Recruiting
State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital"
Yaroslavl, 150000
About this study
Official title: An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis
The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Secondary objectives are to evaluate the pharmacodynamic (PD) profile, the long-term efficacy and safety of olokizumab in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years.
Read the detailed description
This study is a multicenter, open-label, non-randomized, uncontrolled study with an interim analysis of endpoints after 12 weeks of therapy, a final analysis of endpoints after 24 weeks of therapy, and an additional analysis at the end of all study visits.
The total number of study subjects screened is 71 subjects. Up to 50 patients will begin treatment.
This study includes:
- A screening period of up to 2 weeks
- A main period of open label treatment from Week 0 to Week 24 (24 weeks)
- A period of extended open label treatment from Week 24 to Week 164 (140 weeks)
- Safety follow-up period from Week 165 to Week 186 (22 weeks)
The total study duration for patients is approximately 188 weeks (including the screening period).
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- OKZ q4w
- Keywords
- olokizumab, interleukin-6 (IL-6), C-reactive protein (CRP), Musculoskeletal Diseases, Autoimmune Diseases, Rheumatic Diseases Connective Tissue Diseases, Arthritis, Juvenile Arthritis
- Medical subject headings
- Arthritis, Juvenile, Musculoskeletal Diseases, Autoimmune Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKZ q4wDrug
Also called Artlegia
Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
OKZ q4wDrug
Also called Artlegia
SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: OKZ 64 mg q4w | Experimental | SC injections q4w-Cohort 1 Receives: Drug: OKZ q4w |
| Arm 2: OKZ 48 mg q4w | Experimental | SC injections q4w-Cohort 2 Receives: Drug: OKZ q4w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olokizumab Cmax (W24) (maximum concentration) over 24 weeks
The Cmax is defined as maximum serum concentration of olokizumab
Measured: 24 weeks
Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks
The AUC0-W24 is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-W24)
Measured: 24 weeks
Secondary outcomes (7)
Minimum drug concentration at steady state (Ctrough,ss)
The Ctrough is defined as concentration observed before treatment administration during repeated dosing at steady state
Measured: 24 weeks
Maximum concentration (Cmax) of olokizumab after the first administration
The Cmax is defined as maximum serum concentration of olokizumab
Measured: 4 weeks
Time to reach maximum concentration (tmax) of olokizumab after the first administration
T(max) is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of olokizumab
Measured: 4 weeks
The area under the concentration-time curve (AUCtau) of olokizumab over the study period
The AUCtau is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-tau)
Measured: 12, 24, 72 weeks
Concentration before the next dose of olokizumab (Ctrough)
The Ctrough is defined as concentration observed before the next dose of olokizumab during repeated dosing
Measured: 12, 24, 72 weeks
Time to steady state (tss)
Time to reach steady state will be assessed both graphically and statistically. The statistical approach will involve fitting a repeated measures linear mixed model to natural log-transformed data, using Helmert contrasts to compare earlier and later weeks, and identifying the earliest week where the mean concentration difference is not statistically significant
Measured: 12, 24, 72 weeks
Area under the concentration-time curve in the steady state (AUCss)
The АUCss is defined as the area under the curve of the plasma concentration of the drug in the dosing interval at steady state
Measured: 24, 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start17 Mar 2023
- Primary completionSep 2026 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients treat with olokizumab SC q4w
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R-Pharm International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R-Pharm, Keystat, LLC, Exacte Labs LLC
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517575
- Sponsor's protocol ID
- CL04041182
- Status last verified
- Apr 2026
- First submitted
- 30 Dec 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT07517575
- Acronym / sponsor ID
- CL04041182
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- olokizumab, interleukin-6 (IL-6), C-reactive protein (CRP), Musculoskeletal Diseases, Autoimmune Diseases, Rheumatic Diseases Connective Tissue Diseases, Arthritis, Juvenile Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- R-Pharm International, LLCIndustry (pharma, biotech, devices)
- Collaborators
- R-Pharm, Keystat, LLC, Exacte Labs LLC
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Secondary objectives are to evaluate the pharmacodynamic (PD) profile, the long-term efficacy and safety of olokizumab in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years.
Detailed description
This study is a multicenter, open-label, non-randomized, uncontrolled study with an interim analysis of endpoints after 12 weeks of therapy, a final analysis of endpoints after 24 weeks of therapy, and an additional analysis at the end of all study visits.
The total number of study subjects screened is 71 subjects. Up to 50 patients will begin treatment.
This study includes:
- A screening period of up to 2 weeks
- A main period of open label treatment from Week 0 to Week 24 (24 weeks)
- A period of extended open label treatment from Week 24 to Week 164 (140 weeks)
- Safety follow-up period from Week 165 to Week 186 (22 weeks)
The total study duration for patients is approximately 188 weeks (including the screening period).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients treat with olokizumab SC q4w
| Arm | Type | Receives |
|---|---|---|
| Arm 1: OKZ 64 mg q4w | Experimental | Drug: OKZ q4wSC injections q4w-Cohort 1 |
| Arm 2: OKZ 48 mg q4w | Experimental | Drug: OKZ q4wSC injections q4w-Cohort 2 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Study informed consent form voluntarily and independently signed by patient legal representative
- Study assent form voluntarily and independently signed by minor study subject (patient)
- Male or female patients aged ≥12 and <18 years (cohort 1 - subgroup A) or >2 and <12 years (cohort 1 - subgroup B) or >2 and <18 years (cohort 2) at the time of screening initiation and on Day 0
- Body weight at the start of screening and on Day 0 ≥45 kg (cohort 1 - subgroup A) or ≥30 and <45 kg (cohort 1 - subgroup B) or ≥18 and <30 kg (cohort 2)
- A reliable diagnosis of juvenile idiopathic arthritis (JIA) according to the JIA International League of Associations for Rheumatology (ILAR) 1 criteria with onset before the age of 16 years:
Key exclusion criteria (20 listed)
- Prior use of any drug that acts directly on IL-6 or IL-6R
- If methotrexate is administered - any change in dose or in a formulation within 6 weeks prior to Day 0
- Previous therapy with marketed or experimental conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying anti-rheumatic drugs (bDMARDs) within less than 5 elimination half-lives
- Use of oral steroids in the doses above 0.2 mg/kg or 10 mg/day of prednisolone daily, whatever is lower, or a change in dose within 2 weeks prior to Day 0, or use of parenteral or topical steroids within 4 weeks prior to Day 0
- Change in dose of a non-steroidal anti-inflammatory drug (NSAID) within ≤2 weeks prior to Day 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKZ q4wAlso: ArtlegiaSubcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection | Drug | Arm 1: OKZ 64 mg q4w |
| OKZ q4wAlso: ArtlegiaSC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection | Drug | Arm 2: OKZ 48 mg q4w |
Primary outcome
Olokizumab Cmax (W24) (maximum concentration) over 24 weeks
Time frame: 24 weeks
The Cmax is defined as maximum serum concentration of olokizumab
Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks
Time frame: 24 weeks
The AUC0-W24 is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-W24)
7 secondary outcomes
Minimum drug concentration at steady state (Ctrough,ss)
Time frame: 24 weeks
Maximum concentration (Cmax) of olokizumab after the first administration
Time frame: 4 weeks
Time to reach maximum concentration (tmax) of olokizumab after the first administration
Time frame: 4 weeks
The area under the concentration-time curve (AUCtau) of olokizumab over the study period
Time frame: 12, 24, 72 weeks
Concentration before the next dose of olokizumab (Ctrough)
Time frame: 12, 24, 72 weeks
Time to steady state (tss)
Time frame: 12, 24, 72 weeks
Area under the concentration-time curve in the steady state (AUCss)
Time frame: 24, 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mikhail Samsonov study director
R-Pharm
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OKZ q4w in people with Juvenile Idiopathic Arthritis, run by R-Pharm International, LLC at 14 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 11 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Anna Karpenko (+7 (495) 956-79-37 ext. 1552, karpenko@rpharm.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olokizumab Cmax (W24) (maximum concentration) over 24 weeks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.