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New hope for kids with arthritis: Long-Term drug study launches

NCT ID NCT07553182

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This study is testing the long-term safety and effectiveness of the drug filgotinib in children and adolescents aged 8 to 17 with juvenile idiopathic arthritis. Participants must have already completed a previous filgotinib study and shown improvement. The goal is to see if the drug remains safe and helps control arthritis symptoms over time.

What this could mean

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

Active substance
filgotinib
What this could lead to
If successful, this could confirm filgotinib as a safe long-term treatment option for children and teens with juvenile idiopathic arthritis.
What could go wrong
This is an open-label extension study, so there is no placebo group for comparison. Long-term side effects are still being monitored, and the results may not apply to all patients.

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 80 people

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

Started

Apr 2026

Expected to finish

Dec 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 must have completed treatment with filgotinib in at least one parent study and achieved a clinical benefit at the end of the parent protocols * 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 informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any protocol 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 * 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 clinical study protocol. Exclusion Criteria: * Development of any condition during the parent study that would preclude safe continuation * Pregnancy * Active infection that is clinically significant, as per Investigator's judgement * Subject with known hypersensitivity to the components of potential study therapy * Subjects with 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

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis systemic-onset juvenile idiopathic arthritis

As listed by the trial registrant

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

Juvenile idiopathic arthritis (JIA)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asklepios Klinik Sankt Augustin GmbH

    NOT_YET_RECRUITING

    Sankt Augustin, 53757, Germany

  • Bicetre Hospital

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Great Ormond Street Hospital for Children

    NOT_YET_RECRUITING

    London, WC1N 3JH, United Kingdom

  • Hamburger Zentrum für Kinder- und Jugendrheumatologie

    RECRUITING

    Hamburg, 22081, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.