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New arthritis drug for kids shows promise in early trial

NCT ID NCT07517575

Disease control Sponsor: R-Pharm International, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a drug called olokizumab in children aged 2 to 18 with active juvenile idiopathic arthritis. The drug is given as a shot under the skin every 4 weeks. Researchers want to see how the drug moves through the body, if it helps control arthritis symptoms, and if it is safe. About 71 children will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
olokizumab (Artlegia), a drug given as a shot under the skin every 4 weeks
What this could lead to
If successful, this could provide a new treatment option for children with juvenile idiopathic arthritis to better control their disease.
What could go wrong
This is an early phase 2 study with only 71 participants, so results may not apply to all children. The drug may not work as well as hoped or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 71 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

arthritic joint disease autoimmune disease juvenile idiopathic arthritis musculoskeletal system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Juvenile idiopathic arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 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)

    RECRUITING

    Moscow, 119435, Russia

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

    RECRUITING

    Moscow, 119991, Russia

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

    RECRUITING

    Ufa, 450083, Russia

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

    RECRUITING

    Kazan', 420012, Russia

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

    RECRUITING

    Rostov-on-Don, 344022, 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

    RECRUITING

    Saratov, 410054, Russia

  • 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

    RECRUITING

    Voronezh, 394036, Russia

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

    RECRUITING

    Moscow, 115522, Russia

  • LLC "Medical Technologies"

    RECRUITING

    Saint Petersburg, 192148, Russia

  • Limited Liability Company "Healthy Family Medical Center"

    RECRUITING

    Novosibirsk, 630099, Russia

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

    RECRUITING

    Stavropol, 55000, Russia

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

    RECRUITING

    Tolyatti, 445039, 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")

    RECRUITING

    Moscow, 119049, Russia

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

    RECRUITING

    Yaroslavl, 150000, Russia

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