Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
NCT ID: NCT06222034
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2024-05-13
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Filgotinib Dose A
Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\<25 kg
Filgotinib
Film-coated mini-tablets administered orally once daily
Filgotinib Dose B
Dose B of filgotinib tablet for participants with BW ≥25-\<60 kg
Filgotinib
Commercially developed film-coated tablet administered orally once daily
Filgotinib Dose C
Dose C of filgotinib tablet for participants with BW ≥60 kg
Filgotinib
Commercially developed film-coated tablet administered orally once daily
Interventions
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Filgotinib
Film-coated mini-tablets administered orally once daily
Filgotinib
Commercially developed film-coated tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must meet the International League of Associations for Rheumatology classification for 1 of the following categories and have, according to the investigator's judgment, moderately to severely active disease that is not adequately controlled with his/her current therapy.
* Rheumatoid factor (RF)-positive polyarthritis
* RF-negative polyarthritis
* Oligoarthritis
* Psoriatic arthritis
* Enthesis-related arthritis (ERA) Note: Historical Human leukocyte antigen B-27 (HLA-B27) results are considered appropriate for ERA diagnosis during screening.
* Systemic JIA with active arthritis without active systemic features, or with active systemic features that are stable in the prior 6 months of time of enrollment
* Participant with intolerance or a history of inadequate response to at least one of the following medications for the treatment of JIA, administered for at least 12 weeks, based on current treatment guidelines: conventional synthetic disease-modifying antirheumatic drugs and biological disease-modifying antirheumatic drugs (including methotrexate) and non-steroidal anti-inflammatory drugs for ERA and psoriatic arthritis.
* Female participants of childbearing potential (i.e. who have passed menarche) must have a negative highly sensitive urine pregnancy test.
Exclusion Criteria
* Participant with undifferentiated arthritis.
* Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis).
* Active infection that is clinically significant, as per judgment of the investigator.
* Participant with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
* Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, or atypical mycobacteria).
8 Years
18 Years
ALL
No
Sponsors
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Alfasigma S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Alfasigma Study Director
Role: STUDY_DIRECTOR
Alfasigma S.p.A.
Locations
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CHU Amiens - Hopital Nord
Amiens, , France
Bicêtre University Hospital
Le Kremlin-Bicêtre, , France
Children's university hospital Charité, Campus Virchow, SPZ
Berlin, , Germany
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, , Germany
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, , Germany
Malopolskie Badania Kliniczne
Krakow, , Poland
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Sant Joan de Deu
Barcelona, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Great Ormond Street Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-505844-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
GLPG0634-CL-131
Identifier Type: -
Identifier Source: org_study_id
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