Polyarticular Course Juvenile Idiopathic ArthritisPhase 3GALAHOPPERNCT07554495
Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents
A Phase 3 study testing Filgotinib in people with Polyarticular Course Juvenile Idiopathic Arthritis, run by Alfasigma S.p.A. at 14 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Polyarticular Course Juvenile Idiopathic Arthritis
- 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
- 65 participants
- Where
- 14 sitesin 9 countries
- Study dates
- 21 May 2026to Jun 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 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
Show all 10Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
14 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 9 countries
Poland3 sites, 3 recruiting
- Recruiting
Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk
Bydgoszcz, 85-092
Elzbieta Grzesk
- Recruiting
MICS Centrum Medyczne Torun
Torun, 87-100
Slawomir Jeka
- Recruiting
ETG JustMed
Warsaw, 01-696
Marta Szwarc Bronikowska
United Kingdom3 sites, 3 recruiting
- Recruiting
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
Athimalaipet Ramanan
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
Khulood Khawaja
- Recruiting
Nottingham University Hospitals Queen's Medical Centre
Nottingham, NG7 2UH
Satyapal Rangaraj
Germany2 sites, 2 recruiting
- Recruiting
Charité - Campus Virchow-Klinikum
Berlin, 13353
Kirsten Minden
- Recruiting
Hamburger Zentrum fuer Kinder und Jugendrheumatologie
Hamburg, 22089
Ivan Foeldvari
Czechia1 site, 1 recruiting
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12800
Pavla Dolezalova
France1 site, 1 recruiting
- Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Isabelle Kone-Paut
Hungary1 site, 1 recruiting
- Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7623
Bernadett Mosdosi
Italy1 site, 1 recruiting
- Recruiting
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
Genova, 16147
Alessandro Consolaro
Spain1 site, 1 recruiting
- Recruiting
Hospital Sant Joan de Deu
Barcelona, 08950
Jordi Anton Lopez
About this study
Official title: Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Polyarticular-course Juvenile Idiopathic Arthritis
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.
- 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
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. 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
Measured: From baseline (Day 1) the study up to Week 22
Secondary outcomes (9)
Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response
Measured: Week 12 and Week 18
Percentage of subjects with JIA ACR inactive disease
Measured: Week 12 and Week 18
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR)
Measured: Week 12 and Week 18
Change from baseline in Juvenile Arthritis Disease Activity Score JADAS-27 C-reactive protein (CRP)
Measured: Week 12 and Week 18
Incidence of uveitis at various timepoints (including occurrence, type, and severity)
Measured: Week 1, Week 4, Week 8, Week 12, Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including maximum observed plasma concentration at steady-state [Cmax,ss]
Measured: Week 4, Week 12 and Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state [AUC0-24,ss]
Measured: Week 4, Week 12 and Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state for the effective exposure [AUCeff,ss]
Measured: Week 4, Week 12 and Week 18
Acceptability of the age-appropriate pediatric formulation and the adult commercially developed film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)
Measured: Week 4 and Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start21 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyarticular Course Juvenile Idiopathic ArthritisStudies 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Vincent, Study director, Alfasigma S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554495
- Sponsor's protocol ID
- GLPG0634-CL-329
- Other IDs
- 2024-511593-70-00
- Acronym
- GALAHOPPER
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Polyarticular-course Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT07554495
- Acronym / sponsor ID
- GALAHOPPER / GLPG0634-CL-329
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 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 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.
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 (10 listed)
- 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):
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| FilgotinibIP 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. 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
Time frame: From baseline (Day 1) the study up to Week 22
9 secondary outcomes
Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response
Time frame: Week 12 and Week 18
Percentage of subjects with JIA ACR inactive disease
Time frame: Week 12 and Week 18
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR)
Time frame: Week 12 and Week 18
Change from baseline in Juvenile Arthritis Disease Activity Score JADAS-27 C-reactive protein (CRP)
Time frame: Week 12 and Week 18
Incidence of uveitis at various timepoints (including occurrence, type, and severity)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including maximum observed plasma concentration at steady-state [Cmax,ss]
Time frame: Week 4, Week 12 and Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state [AUC0-24,ss]
Time frame: Week 4, Week 12 and Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state for the effective exposure [AUCeff,ss]
Time frame: Week 4, Week 12 and Week 18
Acceptability of the age-appropriate pediatric formulation and the adult commercially developed film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)
Time frame: Week 4 and Week 18
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 12 Jun 2026.
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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.
Catherine Vincent study director
Alfasigma S.p.A.
14 sites in 9 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 Polyarticular Course Juvenile Idiopathic Arthritis, run by Alfasigma S.p.A. at 14 sites in 9 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 10 inclusion and 8 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Poland, United Kingdom, Germany, Belgium, Czechia and 4 more countries. 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 Medical Information (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 (time frame: From baseline (Day 1) the study up to Week 22). 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 12 Jun 2026.