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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07553182
- Acronym / sponsor ID
- OLE JIA / GLPG0634-CL-333
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | Experimental | Drug: FilgotinibFilgotinib |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibInvestigational 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) | Drug | Filgotinib |
Primary outcome
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.
Time frame: From baseline (Day 1) up to Week 78
4 secondary outcomes
Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.
Time frame: Week 1, Week 26, Week 52 and Week 78
Percentage of subjects with JIA ACR inactive disease.
Time frame: Week 1, Week 26, Week 52 and Week 78
Percentage of subjects with JIA ACR clinical remission over time.
Time frame: Week 1, Week 26, Week 52 and Week 78
Incidence of treatment-emergent uveitis (including severity).
Time frame: Week 1, Week 26, Week 52, Week 78
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Vincent (00800 7878 1345, medicalinfo@alfasigma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From baseline (Day 1) up to Week 78). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.