An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis
New study tests olokizumab for children and teens with active juvenile arthritis
Plain English Summary
Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis is a Phase 2 clinical trial sponsored by R-Pharm International, LLC studying Juvenile Idiopathic Arthritis. This study is testing a drug called olokizumab to see how it works in young people with active juvenile idiopathic arthritis. It is for patients aged 2 to 17 years who have been diagnosed with certain types of juvenile idiopathic arthritis and have not responded well to methotrexate. Participation involves receiving injections of olokizumab every 4 weeks, with regular check-ups and blood tests. Alternative treatments for juvenile idiopathic arthritis include other medications like methotrexate, other biologic drugs, and supportive therapies. The trial aims to enroll 71 participants.
Official 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
Here is what you need to know about eligibility for this trial. Children and adolescents aged 2 to 17 years can join. Patients must have a confirmed diagnosis of juvenile idiopathic arthritis (JIA) that has been active for at least 3 months. Participants should have at least 5 active joints and a specific level of inflammation (CRP). Patients who have previously used drugs targeting IL-6 or IL-6 receptors, or have certain other medical conditions like active uveitis or tuberculosis, cannot participate. This trial is studying Juvenile Idiopathic Arthritis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how much of the drug is in the body over time, helping doctors understand how the drug is absorbed and processed to ensure it's given at the right dose. The specific primary outcome measures are: Olokizumab Cmax (W24) (maximum concentration) over 24 weeks (24 weeks); Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks (24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial is important because it aims to find a new treatment option for children and adolescents with active juvenile idiopathic arthritis, addressing a need for effective therapies in this populat Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Juvenile Idiopathic Arthritis, where improved treatment options are needed.
Investor Insight
This trial signals potential for a new biologic treatment for a significant pediatric autoimmune disease, with the market for JIA treatments being substantial and competitive. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of olokizumab, and how it compares to other available treatments. Participation involves regular clinic visits for injections, blood tests, and physical examinations. You will need to provide signed consent and assent forms, and your legal representative will also sign the consent form. This trial is currently recruiting participants. The trial is being conducted at 14 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 71 participants
Interventions
- DRUG: OKZ q4w — Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
- DRUG: OKZ q4w — SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
Primary Outcomes
- Olokizumab Cmax (W24) (maximum concentration) over 24 weeks (24 weeks)
- Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks (24 weeks)
Secondary Outcomes
- Minimum drug concentration at steady state (Ctrough,ss) (24 weeks)
- Maximum concentration (Cmax) of olokizumab after the first administration (4 weeks)
- Time to reach maximum concentration (tmax) of olokizumab after the first administration (4 weeks)
- The area under the concentration-time curve (AUCtau) of olokizumab over the study period (12, 24, 72 weeks)
- Concentration before the next dose of olokizumab (Ctrough) (12, 24, 72 weeks)
Full Eligibility Criteria
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
Trial Locations
- Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation, Kazan', Russia
- Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology", Moscow, Russia
- 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
- 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
- Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation, Moscow, Russia
- Limited Liability Company "Healthy Family Medical Center", Novosibirsk, Russia
- 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
- LLC "Medical Technologies", Saint Petersburg, Russia
- 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
- Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM"), Stavropol, Russia
- ...and 4 more locations
Frequently Asked Questions
What is clinical trial NCT07517575?
NCT07517575 is a Phase 2 INTERVENTIONAL study titled "Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis." It is currently recruiting and is sponsored by R-Pharm International, LLC. The trial targets enrollment of 71 participants.
What conditions does NCT07517575 study?
This trial investigates treatments for Juvenile Idiopathic Arthritis. The primary condition under study is Juvenile Idiopathic Arthritis.
What treatments are being tested in NCT07517575?
The interventions being studied include: OKZ q4w (DRUG), OKZ q4w (DRUG). Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection
What does Phase 2 mean for NCT07517575?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07517575?
This trial is currently "Recruiting." It started on 2023-03-17. The estimated completion date is 2030-06.
Who is sponsoring NCT07517575?
NCT07517575 is sponsored by R-Pharm International, LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07517575?
The trial aims to enroll 71 participants. The trial is currently recruiting and accepting new participants.
How is NCT07517575 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07517575?
The primary outcome measures are: Olokizumab Cmax (W24) (maximum concentration) over 24 weeks (24 weeks); Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks (24 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07517575 being conducted?
This trial is being conducted at 14 sites, including Kazan'; Moscow; Novosibirsk; Rostov-on-Don and 10 more sites (Russia).
Where can I find official information about NCT07517575?
The official record for NCT07517575 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07517575. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07517575 testing in simple terms?
This study is testing a drug called olokizumab to see how it works in young people with active juvenile idiopathic arthritis. It is for patients aged 2 to 17 years who have been diagnosed with certain types of juvenile idiopathic arthritis and have not responded well to methotrexate.
Why is this trial significant?
This trial is important because it aims to find a new treatment option for children and adolescents with active juvenile idiopathic arthritis, addressing a need for effective therapies in this populat
What are the potential risks of participating in NCT07517575?
Common side effects may include injection site reactions, upper respiratory tract infections, and headaches. More serious risks could involve increased susceptibility to infections, allergic reactions, or liver problems. The study drug targets the immune system, which could potentially affect the body's ability to fight off infections. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07517575?
Ask your doctor about the potential benefits and risks of olokizumab, and how it compares to other available treatments. Participation involves regular clinic visits for injections, blood tests, and physical examinations. You will need to provide signed consent and assent forms, and your legal representative will also sign the consent form. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07517575 signal from an investment perspective?
This trial signals potential for a new biologic treatment for a significant pediatric autoimmune disease, with the market for JIA treatments being substantial and competitive. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves receiving injections of olokizumab every 4 weeks, with regular check-ups and blood tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Juvenile Idiopathic Arthritis Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.