Juvenile Idiopathic Arthritis (JIA)Phase 3OLE JIANCT07553182
OLE Study With Filgotinib in JIA
A Phase 3 study testing Filgotinib in people with Juvenile Idiopathic Arthritis (JIA), run by Alfasigma S.p.A. at 4 sites in 3 countries.
Trial summary
This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 20 Apr 2026to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Hamburg, 22081
Ivan Foeldvari, Dr.
- Not yet recruiting
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, 53757
Gerd Horneff, Dr
France1 site, 1 recruiting
- Recruiting
Bicetre Hospital
Le Kremlin-Bicêtre, 94270
Isabelle Kone-Paut, Dr.
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Great Ormond Street Hospital for Children
London, WC1N 3JH
Sandrine Lacassagne, Dr.
About this study
Official title: Open-label Extension (OLE), Multiple Dose Study to Evaluate Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Being tested
- Filgotinib
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Investigational product (IP) will be provided as commercially developed film-coated tablets or age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally once daily (q.d.) at approximately the same time every morning (with or without food)
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib | Experimental | Filgotinib Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.
Measured: From baseline (Day 1) up to Week 78
Secondary outcomes (4)
Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.
Measured: Week 1, Week 26, Week 52 and Week 78
Percentage of subjects with JIA ACR inactive disease.
Measured: Week 1, Week 26, Week 52 and Week 78
Percentage of subjects with JIA ACR clinical remission over time.
Measured: Week 1, Week 26, Week 52 and Week 78
Incidence of treatment-emergent uveitis (including severity).
Measured: Week 1, Week 26, Week 52, Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start20 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553182
- Sponsor's protocol ID
- GLPG0634-CL-333
- Other IDs
- 2025-523239-21-00, 2025
- Acronym
- OLE JIA
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No