Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis (NCT07517575) | Clinical Trial Compass
RecruitingPhase 2
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
Russia71 participantsStarted 2023-03-17
Plain-language 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. 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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Olokizumab Cmax (W24) (maximum concentration) over 24 weeks
Timeframe: 24 weeks
2
Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks
✕. 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