At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Filgotinib (drug)
- How long the study runs
- Study runs about 13 months (dates as stated)
- About the drug or intervention
- Filgotinib — drug: IP will be provided as commercially developed film-coated tablets or age-appropriate film- coated tablets for use in paediatric subjects aged at least 8 years and needs to be taken orally q.d.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how safe filgotinib is, how well the body handles it, and whether it helps children and teenagers aged 8 to under 18 with polyarticular-course juvenile idiopathic arthritis (JIA), a type of childhood arthritis affecting many joints. It is for young people whose arthritis is moderately to severely active and not adequately controlled by their current treatment.
Who can take part
- Aged 8 to under 18, female or male
- Has one of these types of juvenile arthritis: extended oligoarthritis (more than 4 joints affected after the first 6 months), rheumatoid factor (RF)-positive polyarthritis, RF-negative polyarthritis, psoriatic arthritis, or enthesitis-related arthritis
- Disease is moderately to severely active and not adequately controlled with current therapy
- Has had an inadequate response to, or cannot tolerate, at least one arthritis medicine taken for at least 3 months (such as methotrexate, other disease-modifying medicines, biologic medicines, or for some types, anti-inflammatory painkillers)
- Able and willing to follow the study requirements, with consent from the subject and/or parent or guardian
- Sexually active females who could become pregnant must agree to use contraception as described in the study plan
Who may not be able to
- Weighs under 15 kg
- Has persistent oligoarthritis (no more than 4 joints affected throughout the disease)
- Has undifferentiated arthritis
- Has or had uncontrolled anterior uveitis (eye inflammation) within 12 weeks before the start
- Has systemic juvenile idiopathic arthritis (JIA)
- Has another rheumatic, inflammatory, or immune disease (for example inflammatory bowel disease or lupus)
- Has an active infection
- Has had a severe form of shingles (herpes zoster) affecting multiple areas, spreading widely, or affecting the eyes or brain
- Any other condition, including unusual blood test results, that in the researcher's opinion makes completing the study unlikely
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 8 Years to 18 Years
- Who
- All
- Number of participants
- 65
- Started
- 2026-05-21
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for polyarticular course juvenile idiopathic arthritis
- • Phase3 - 65 participants
- • This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks
Who can take part?
- • Ages 8 Years to 18 Years
- • Diagnosed with polyarticular course juvenile idiopathic arthritis
Where?
- • Bristol - Bristol Royal Hospital for Children
- • Leicester - Leicester Royal Infirmary
- • Nottingham - Nottingham University Hospitals Queen's Medical Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 8 Years - 18 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board,
What the study is looking for
- ✓Female or male subject 8 to \<18 years of age, on the date of signing the agreement to take part and assent (per local...
- ✓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
- ✓Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use...
Who cannot take part
- ✗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.
See the full criteria
Where Is This Study? (3 UK sites)
Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Nottingham University Hospitals Queen's Medical Centre
Nottingham NG7 2UH, United Kingdom
How to Get in Touch
Medical Information
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