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

NCT07517575 | Recruiting Phase 2 DMC

• 1 other identifier: CL04041182
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

olokizumab; interleukin-6 (IL-6); C-reactive protein (CRP); Musculoskeletal Diseases; Autoimmune Diseases; Rheumatic Diseases Connective Tissue Diseases; Arthritis; Juvenile Arthritis

Outcome Measures

Primary Outcomes (2)

• Olokizumab Cmax (W24) (maximum concentration) over 24 weeks

  The Cmax is defined as maximum serum concentration of olokizumab

  24 weeks

• Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks

  The AUC0-W24 is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-W24)

  24 weeks

Secondary Outcomes (7)

• 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

Other Outcomes (26)

• Treatment response, based on Juvenile idiopathic Arthritis American College of Rheumatology (JIA ACR) 30, 50, 70 and 90 criteria over the study period

  24, 72, 164 weeks

• Changes in Juvenile Arthritis Disease Activity Score-10 (JADAS-10) over the study period

  24, 72, 164 weeks

• Changes in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) over the study period

  24, 72, 164 weeks

Study Arms (2)

Arm 1: OKZ 64 mg q4w

EXPERIMENTAL

SC injections q4w-Cohort 1

Drug: OKZ q4w

Arm 2: OKZ 48 mg q4w

EXPERIMENTAL

SC injections q4w-Cohort 2

Drug: OKZ q4w

Interventions

OKZ q4w DRUG

Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection

Also known as: Artlegia

Arm 1: OKZ 64 mg q4w

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• 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

Sponsors & Collaborators

• R-Pharm International, LLC: lead
• Exacte Labs LLC: collaborator
• R-Pharm: collaborator
• Keystat, LLC: collaborator

Study Sites (14)

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation

Kazan', 420012, Russia

RECRUITING

Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"

Moscow, 115522, 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, 119049, 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, 119435, Russia

RECRUITING

Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation

Moscow, 119991, Russia

RECRUITING

Limited Liability Company "Healthy Family Medical Center"

Novosibirsk, 630099, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation

Rostov-on-Don, 344022, Russia

RECRUITING

LLC "Medical Technologies"

Saint Petersburg, 192148, Russia

RECRUITING

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, 410054, Russia

RECRUITING

Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")

Stavropol, 55000, Russia

RECRUITING

State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5"

Tolyatti, 445039, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation

Ufa, 450083, Russia

RECRUITING

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, 394036, Russia

RECRUITING

State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital"

Yaroslavl, 150000, Russia

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile; Musculoskeletal Diseases; Autoimmune Diseases; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Central Study Contacts

Anna Karpenko

CONTACT

+7 (495) 956-79-37; karpenko@rpharm.ru

Darya Bukhanova

CONTACT

+7 (495) 956-79-37; bukhanova@rpharm.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients treat with olokizumab SC q4w

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: April 8, 2026
• Study Start: March 17, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

RU (14)