Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for kids with arthritis: drug trial launches

NCT ID NCT06668181

Disease control Sponsor: UCB Biopharma SRL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 3 times

Summary

This study tests a drug called bimekizumab in children aged 2 to 17 with specific types of juvenile arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis). The goal is to see how the drug moves through the body and if it is safe. About 40 children will take part, receiving the drug as a shot under the skin.

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 40 people

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

Started

Mar 2025

Expected to finish

Jul 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 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: * Study participant must be 2 to \<18 years of age inclusive, at the Baseline Visit. * Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 3 months duration prior to the Screening Visit. * Study participants who have active disease (ERA \[including JAS\] and/or JPsA) defined as having at least 3 active joints, each of which needs to be included in the joints assessed in the JADAS27, and for ERA at least 1 site of enthesitis at Baseline or documented by history. * Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID). * Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.) * Study participants with no concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs with the exception of methotrexate or sulfasalazine. * Body weight of ≥10kg. * Male and female. * A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period) * Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol. Exclusion Criteria: * Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA). * Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD. * Study participant has active uncontrolled uveitis. * Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated. * Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study. * Study participant has laboratory abnormalities at Screening defined in the Protocol. * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections). * Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments. * Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier. * Study participant had prior treatment with more than one biologic response modifier (other than an IL-17). * Presence of active suicidal ideation, or positive suicide behavior. * Study participant has been diagnosed with severe depression in the past 6 months.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Enthesitis related arthritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

arthritic joint disease enthesitis-related juvenile idiopathic arthritis juvenile ankylosing spondylitis juvenile idiopathic arthritis psoriasis-related juvenile idiopathic arthritis

As listed by the trial registrant

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

Enthesitis related arthritis Juvenile psoriatic arthritis

How to take part

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

  1. The places running it

    22 sites in 6 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

  • Ja0005 40072

    RECRUITING

    Freiburg im Breisgau, Germany

  • Ja0005 40100

    RECRUITING

    Madrid, Spain

  • Ja0005 40356

    RECRUITING

    Dresden, Germany

  • Ja0005 40369

    RECRUITING

    Berlin, Germany

  • Ja0005 40427

    RECRUITING

    Tübingen, Germany

  • Ja0005 40510

    RECRUITING

    Le Kremlin-Bicêtre, France

  • Ja0005 40720

    RECRUITING

    Krakow, Poland

  • Ja0005 40776

    RECRUITING

    Poitiers, France

  • Ja0005 40777

    RECRUITING

    Indre-et-Loire, France

  • Ja0005 40778

    RECRUITING

    Paris, France

  • Ja0005 40779

    RECRUITING

    Sendenhorst, Germany

  • Ja0005 40780

    RECRUITING

    Sosnowiec, Poland

  • Ja0005 40781

    RECRUITING

    Esplugues de Llobregat, Spain

  • Ja0005 40782

    RECRUITING

    Valencia, Spain

  • Ja0005 40783

    RECRUITING

    Manchester, United Kingdom

  • Ja0005 40784

    ACTIVE_NOT_RECRUITING

    Stroke-on-trent, United Kingdom

  • Ja0005 40785

    RECRUITING

    Nottingham, United Kingdom

  • Ja0005 40786

    RECRUITING

    Bristol, United Kingdom

  • Ja0005 40787

    RECRUITING

    Sankt Augustin, Germany

  • Ja0005 40852

    RECRUITING

    Hamburg, Germany

  • Ja0005 50644

    RECRUITING

    Montreal, Canada

  • Ja0005 50645

    RECRUITING

    Saskatoon, Canada

  • Ja0005 50646

    RECRUITING

    Calgary, Canada

More trials for these conditions

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