Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

olokizumabinterleukin-6 (IL-6)C-reactive protein (CRP)Musculoskeletal DiseasesAutoimmune DiseasesRheumatic Diseases Connective Tissue DiseasesArthritisJuvenile 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
+2 more secondary outcomes

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
+23 more other outcomes

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 q4wDrug

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

OKZ q4wDrug

SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection

Also known as:

Eligibility Criteria

Age2 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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)

Sponsors & Collaborators

Exacte Labs LLC
Industrycollaborator
Keystat, LLC
Industrycollaborator
R-Pharm

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

MeSH Terms

Conditions

Arthritis, JuvenileMusculoskeletal DiseasesAutoimmune DiseasesArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune 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

Study Design

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

Study Record Dates

First Submitted

December 30, 2025

First Posted

April 8, 2026

Study Start

March 17, 2023

Actual (reported)

Primary Completion

September 2026

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
+2 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Other Outcomes (26)

Study Arms (2)

Arm 1: OKZ 64 mg q4w

Arm 2: OKZ 48 mg q4w

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Other Outcomes (26)

Study Arms (2)

Arm 1: OKZ 64 mg q4w

Arm 2: OKZ 48 mg q4w

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations