Olokizumab treatment for children with polyarticular juvenile idiopathic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, non-randomized Phase 2 PK/efficacy and safety study of olokizumab in children with polyarticular juvenile idiopathic arthritis. Patients are assigned weight-based doses (48 mg or 64 mg) given every four weeks, with PK as the primary objective and PD, efficacy, and long-term safety as secondary objectives. The protocol includes a screening period, a 24-week main treatment period with interim analysis at 12 weeks, an extended open-label treatment phase up to Week 164, and a safety follow-up to Week 186. Up to 50 patients will start treatment, and multiple Russian pediatric rheumatology centers are enrolling participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Study informed consent form voluntarily and independently signed by patient legal representative
2. Study assent form voluntarily and independently signed by minor study subject (patient)
3. 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
4. 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)
5. 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:

   1. Seropositive or seronegative polyarthritis (pJIA) ≥3 months before screening, or
   2. Systemic JIA (sJIA) for ≥3 months before screening, provided that joint symptoms persist without active systemic manifestations for ≥3 months before screening, or
   3. Extended oligoarticular JIA (оJIA) ≥3 months before screening
6. American College of Radiology (ACR) criteria of active polyarthritis are met: 5 or more active joints at screening and on Day 0
7. 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
8. 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

Exclusion Criteria:

1. Prior use of any drug that acts directly on IL-6 or IL-6R
2. If methotrexate is administered - any change in dose or in a formulation within 6 weeks prior to Day 0
3. 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
4. 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
5. Change in dose of a non-steroidal anti-inflammatory drug (NSAID) within ≤2 weeks prior to Day 0
6. 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
7. Active uveitis at screening or uveitis exacerbation within 24 weeks before screening
8. 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
9. Exclusion criteria related to past or current infection other than tuberculosis
10. Suspected or confirmed current tuberculosis (TB) infection, history of an active or latent TB infection
11. 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
12. Concurrent heart failure New York Heart Association (NYHA) III or IV functional class
13. In patients with diabetes mellitus - HbA1c \> 7% within the last 3 months (non-controlled diabetes mellitus)
14. Patients with Steinbrocker class IV functional impairment
15. Presence of systemic autoimmune or autoinflammatory disease, except JIA, or chronic autoimmune hepatitis or diseases of the primary immunodeficiencies group
16. Patients with history of macrophage activation syndrome episodes
17. Exclusion criteria related to concurrent diseases and conditions that may increase potential risk related to participation in the study and study drug exposure
18. Known hypersensitivity to any component of the study drug
19. Pregnant or breast-feeding female participants or planned pregnancy
20. Other protocol-defined non-inclusion criteria apply

Where it's running

• Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
  Kazan', Russia Recruiting
• Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"
  Moscow, Russia 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, Russia 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, Russia Recruiting
• Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation
  Moscow, Russia Recruiting
• Limited Liability Company "Healthy Family Medical Center"
  Novosibirsk, Russia Recruiting

Study contacts

• Study coordinator: Anna Karpenko
• Email: karpenko@rpharm.ru
• Phone: +7 (495) 956-79-37

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.