[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alfasigma S.p.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,63,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100635577","phase-3-safety-tolerability-pharmacokinetics-and-efficacy-of-filgotinib-for-the-treatment-of-polyarticular-course-juvenile-idiopathic-arthritis-in-children-and-adolescents-100635577",false,"NCT07554495","Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents","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","GALAHOPPER","Inclusion Criteria:\n\n* Subject and\u002For parent\u002Flegal 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 \u002F Institutional Review Board, prior to any screening evaluations.\n* Female or male subject 8 to \\\u003C18 years of age, on the date of signing the informed consent and assent (per local regulation) form.\n* 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\u002Fher current therapy (see Protocol Appendix 1 for disease activity assessment criteria):\n\n  * Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease)\n  * RF-positive polyarthritis\n  * RF-negative polyarthritis\n  * PsA\n  * ERA\n* 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\u002For biologic disease modifying anti-rheumatic drugs (bDMARDs) administered per local label, and\u002For non steroidal anti-inflammatory drugs for ERA and PsA subtypes.\n* Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception\u002Fpreventive exposure measures as described in the protocol.\n\nExclusion Criteria:\n\n* Subject with a body weight \\\u003C15 kg.\n* Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).\n* Subject with undifferentiated arthritis.\n* Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.\n* Subject with systemic JIA.\n* Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus).\n* 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.\n* Subject has an active infection. • Subject with a history of complicated herpes zoster infection (with multi dermatomal, disseminated, ophthalmic, or central nervous system involvement).","ALL","8 Years","18 Years",{"count":21,"type":22},65,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Polyarticular Course Juvenile Idiopathic Arthritis","RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":33},"2026-05-21",{"date":37,"type":22},"2027-06",{"name":39,"class":40},"Alfasigma S.p.A.","INDUSTRY",14,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100582600","phase-3-a-study-evaluating-the-effects-of-filgotinib-in-children-and-teenagers-with-ulcerative-colitis-100582600","NCT06865417","A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis","A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects (8 to \u003C18 Years of Age) With Moderately to Severely Active Ulcerative Colitis","Galapeduca","Inclusion Criteria:\n\n* Subject must have a minimum body weight (BW) of 15 kg.\n* Subject:\n\n  * has documented diagnosis of UC with a minimum duration of 3 months,\n  * has mMCS of 5 to 9, and an MCS endoscopic score \\>=2, rectal bleeding \\>=1, and stool frequency \\>=1,\n  * has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and\u002For biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids.\n\nExclusion Criteria:\n\n* Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon.\n* Subject has an active infection.\n* Subject 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, herpes zoster, or atypical mycobacteria).\n* Subject has a history of colectomy or extensive small bowel resection.\n* Subject with psychological or cognitive difficulties that might interfere with study participation.\n* Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).\n* Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.",{"count":51,"type":22},80,[25],"The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.\n\nApproximately 80 subjects from 8 to \\\u003C18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \\\u003C12 years of age, will be enrolled in this study.\n\nDuring the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food).\n\nSubjects who do not achieve mMCS remission and\u002For MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study.\n\nSubjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.",[55],"Ulcerative Colitis",{"date":32,"type":33},{"date":58,"type":33},"2025-09-29",{"date":60,"type":22},"2028-06",{"name":39,"class":40},47,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":71},"100533147","phase-1-study-to-measure-filgotinib-in-the-blood-of-children-and-teenagers-with-arthritis-taking-filgotinib-scalesia-100533147","NCT06222034","Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)","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","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\u002Fher 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\u002F Exclusion criteria may apply.",{"count":71,"type":22},10,[73],"PHASE1","A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).",[76],"Juvenile Idiopathic Arthritis","2026-05-19",{"date":79,"type":33},"2026-05-22",{"date":81,"type":33},"2024-05-13",{"date":83,"type":22},"2026-08",{"name":39,"class":40},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":5},"100635476","phase-3-ole-study-with-filgotinib-in-jia-100635476","NCT07553182","OLE Study With Filgotinib in JIA","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)","OLE JIA","Inclusion Criteria:\n\n* 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\n* Subject and\u002For parent\u002Flegal 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\u002F Institutional Review Board, prior to any protocol evaluations\n* Female or male subject 8 to \\\u003C18 years of age, on the date of signing the informed consent and assent (per local regulation) form\n* Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception\u002Fpreventive exposure measures as described in the clinical study protocol.\n\nExclusion Criteria:\n\n* Development of any condition during the parent study that would preclude safe continuation\n* Pregnancy\n* Active infection that is clinically significant, as per Investigator's judgement\n* Subject with known hypersensitivity to the components of potential study therapy\n* 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",{"count":51,"type":22},[25],"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\u002Fprolonged 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.",[97],"Juvenile Idiopathic Arthritis (JIA)","2026-04-21",{"date":100,"type":33},"2026-04-27",{"date":102,"type":33},"2026-04-20",{"date":104,"type":22},"2027-12",{"name":39,"class":40},""]