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Looking for participantsPhase3

Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents

Sponsor: Alfasigma S.p.A.

NCT ID: NCT07554495

View on ClinicalTrials.gov ↗

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.

Polyarticular Course Juvenile Idiopathic Arthritis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

PsA

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
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).

Where Is This Study? (3 UK sites)

Bristol Royal Hospital for Children

Bristol BS2 8BJ, United Kingdom

Recruiting

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Nottingham University Hospitals Queen's Medical Centre

Nottingham NG7 2UH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

How to Get in Touch

Medical Information

Sponsor contact

CONTACT

00800 7878 1345 medicalinfo@alfasigma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06