Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis

Recruiting now · Phase 2

Conditions studied: Juvenile Idiopathic Arthritis

In brief

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.

Key facts

Study ID

NCT07517575

Run by

R-Pharm International, LLC

People needed

71

Starts

2023-03-17

Expected to finish

2030-06-01

Last updated by the study team

2026-04-08

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation — Kazan', Russia (enrolling)
• Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology" — Moscow, Russia (enrolling)
• 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, Russia (enrolling)
• 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, Russia (enrolling)
• Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation — Moscow, Russia (enrolling)
• Limited Liability Company "Healthy Family Medical Center" — Novosibirsk, Russia (enrolling)
• Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation — Rostov-on-Don, Russia (enrolling)
• LLC "Medical Technologies" — Saint Petersburg, Russia (enrolling)
• 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, Russia (enrolling)
• Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM") — Stavropol, Russia (enrolling)
• State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5" — Tolyatti, Russia (enrolling)
• Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation — Ufa, Russia (enrolling)
• 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, Russia (enrolling)
• State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital" — Yaroslavl, Russia (enrolling)

Full record on ClinicalTrials.gov

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