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New pill could ease juvenile arthritis in kids

NCT ID NCT07554495

Disease control Sponsor: Alfasigma S.p.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a daily pill called filgotinib in children aged 8 to 17 with a type of arthritis that affects multiple joints. The goal is to see if the drug is safe and helps control the disease over 18 weeks. About 65 participants will take the drug and be monitored for side effects and symptom improvement.

What this could mean

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

Active substance
Filgotinib (a drug taken by mouth as a tablet)
What this could lead to
If successful, this could provide a new treatment option for children with juvenile arthritis, helping control joint inflammation and improve daily function.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may not prove effectiveness. Side effects are possible, and the drug may not work for all children.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 65 people

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

Started

May 2026

Expected to finish

Jun 2027

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

8 to 18 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: * Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening evaluations. * Female or male subject 8 to \<18 years of age, on the date of signing the informed consent and assent (per local regulation) form. * Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria): * Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease) * RF-positive polyarthritis * RF-negative polyarthritis * PsA * ERA * Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDs) administered per local label, and/or non steroidal anti-inflammatory drugs for ERA and PsA subtypes. * Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the protocol. Exclusion Criteria: * Subject with a body weight \<15 kg. * Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course). * Subject with undifferentiated arthritis. * Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline. * Subject with systemic JIA. * Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus). * Subject has any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements. * Subject has an active infection. • Subject with a history of complicated herpes zoster infection (with multi dermatomal, disseminated, ophthalmic, or central nervous system involvement).

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis

As listed by the trial registrant

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

Polyarticular course 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 in 9 countries. 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

  • Bristol Royal Hospital for Children

    RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk

    RECRUITING

    Bydgoszcz, 85-092, Poland

  • Charité - Campus Virchow-Klinikum

    RECRUITING

    Berlin, 13353, Germany

  • ETG JustMed

    RECRUITING

    Warsaw, 01-696, Poland

  • Hamburger Zentrum fuer Kinder und Jugendrheumatologie

    RECRUITING

    Hamburg, 22089, Germany

  • Hospital Sant Joan de Deu

    RECRUITING

    Barcelona, 08950, Spain

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

    RECRUITING

    Genova, 16147, Italy

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • MICS Centrum Medyczne Torun

    RECRUITING

    Torun, 87-100, Poland

  • Nottingham University Hospitals Queen's Medical Centre

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    RECRUITING

    Pécs, 7623, Hungary

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 12800, Czechia

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