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Tests treatment safety and results for Juvenile Idiopathic Arthritis
Official title Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis
ClinicalTrials.gov ID: NCT07517575
What this study is testing
What is OKZ q4w?
OKZ q4w is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for juvenile idiopathic arthritis.
Also referred to as Artlegia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 \ 2 and \<18 years.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join 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 \ 2 and \ 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...
- A reliable diagnosis of juvenile idiopathic arthritis (JIA) according to the JIA International League of Associations for Rheumatology (ILAR) 1...
You likely can't join 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...
- 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...
- 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...
See the full eligibility 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 \ 2 and \ 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
- 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...
- 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...
- 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...
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Kazan', Russia
- Moscow, Russia
- Novosibirsk, Russia
- Rostov-on-Don, Russia
- Saint Petersburg, Russia
- Saratov, Russia
- Stavropol, Russia
- Tolyatti, Russia
- Ufa, Russia
- Voronezh, Russia
- Yaroslavl, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kazan', Russia; Moscow, Russia; Novosibirsk, Russia; Rostov-on-Don, Russia; Saint Petersburg, Russia; Saratov, Russia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.