Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-29 @ 12:07 AM
Study NCT ID:
NCT06222034
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584571', 'term': 'GLPG0634'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-15', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration at steady state of filgotinib (Cmax,ss)', 'timeFrame': 'Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10'}, {'measure': 'Cmax,ss of GS-829845, major active metabolite', 'timeFrame': 'Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10'}, {'measure': 'Area under the plasma concentration-time curve over the dosing interval at steady state of filgotinib (AUC0-24,ss)', 'timeFrame': 'Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10'}, {'measure': 'AUC0-24,ss of GS-829845, major active metabolite', 'timeFrame': 'Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10'}, {'measure': 'Area under the plasma concentration time curve over the dosing interval at steady state or the effective exposure of filgotinib (AUCeff,ss)', 'timeFrame': 'Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10'}, {'measure': 'AUCeff,ss of GS-829845, major active metabolite', 'timeFrame': 'Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (TEAEs), TEAEs of interest, serious TEAEs, and TEAEs leading to treatment discontinuation.', 'timeFrame': 'Baseline (Day 1) up to week 96'}, {'measure': 'Acceptability of the commercially developed film-coated tablets and of the minitablets as measured by the Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P).', 'timeFrame': 'Week 4 and week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Participant with a body mass index (BMI) within the 5th to 95th percentiles for the age and gender (based on World Health Organization BMI charts). Participant must have a minimum weight of 15 kg.\n* 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.\n\n * Rheumatoid factor (RF)-positive polyarthritis\n * RF-negative polyarthritis\n * Oligoarthritis\n * Psoriatic arthritis\n * Enthesis-related arthritis (ERA) Note: Historical Human leukocyte antigen B-27 (HLA-B27) results are considered appropriate for ERA diagnosis during screening.\n * 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\n* 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.\n* Female participants of childbearing potential (i.e. who have passed menarche) must have a negative highly sensitive urine pregnancy test.\n\nKey Exclusion Criteria:\n\n* Participant with persistent oligoarthritis.\n* Participant with undifferentiated arthritis.\n* Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis).\n* Active infection that is clinically significant, as per judgment of the investigator.\n* Participant with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).\n* Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, or atypical mycobacteria).\n\nNote: Other protocol defined Inclusion/ Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06222034', 'briefTitle': 'Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alfasigma S.p.A.'}, 'officialTitle': 'An Open-label, Multiple Dose, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Filgotinib in Children and Adolescents From 8 to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'GLPG0634-CL-131'}, 'secondaryIdInfos': [{'id': '2023-505844-21-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filgotinib Dose A', 'description': 'Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\\<25 kg', 'interventionNames': ['Drug: Filgotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib Dose B', 'description': 'Dose B of filgotinib tablet for participants with BW ≥25-\\<60 kg', 'interventionNames': ['Drug: Filgotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib Dose C', 'description': 'Dose C of filgotinib tablet for participants with BW ≥60 kg', 'interventionNames': ['Drug: Filgotinib']}], 'interventions': [{'name': 'Filgotinib', 'type': 'DRUG', 'otherNames': ['GS-6034', 'GLPG0634'], 'description': 'Film-coated mini-tablets administered orally once daily', 'armGroupLabels': ['Filgotinib Dose A']}, {'name': 'Filgotinib', 'type': 'DRUG', 'otherNames': ['GS-6034', 'GLPG0634', 'Jyseleca'], 'description': 'Commercially developed film-coated tablet administered orally once daily', 'armGroupLabels': ['Filgotinib Dose B', 'Filgotinib Dose C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Amiens - Hopital Nord', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Bicêtre University Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': "Children's university hospital Charité, Campus Virchow, SPZ", 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22081', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Hamburger Zentrum fur Kinder und Jugendrheumatologie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '53757', 'city': 'Sankt Augustin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Asklepios Klinik Sankt Augustin GmbH', 'geoPoint': {'lat': 50.77538, 'lon': 7.197}}, {'zip': '30-002', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Malopolskie Badania Kliniczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08950', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'WC1N 3JH', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Pilar de la Torre', 'role': 'CONTACT', 'email': 'medicalinfo@alfasigma.com', 'phone': '00800 7878 1345'}], 'overallOfficials': [{'name': 'Alfasigma Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alfasigma S.p.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alfasigma S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}