OLE study with filgotinib in JIA

• Research type

  Research Study

• Full 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)

• IRAS ID

  1013461

• Contact name

  Catherine Vincent

• Contact email

  catherine.vincent@alfasigma.com

• Sponsor organisation

  Alfasigma S.p.A.

• Eudract number

  2025-523239-21

• Research summary

  Juvenile idiopathic arthritis (JIA) is an acquired inflammatory disease and one of the most common rheumatic diseases in childhood.
  It typically causes joint pain and inflammation of the joints. Inflammation may affect other organs such as heart, lungs or lymphnodes
  in the systemic form of JIA. The purpose of this study is to access the long-term safety, tolerability, and efficacy of filgotinib in participants from 8 to less than 18 years of age with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA), who have completed the treatment period/prolonged treatment period in one of the previous parent studies (GLPG0634-CL-131, GLPG0634-CL-329, and GLPG0634-CL-328) and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
  All participants who have tolerated treatment with filgotinib and achieved a clinical benefit at the
  end of the parent studies will be enrolled in this open-label extension study. Each participant will be treated for up to 78 weeks or until
  commercialization of filgotinib in the approved indications which ever come first. The study will consist of the following periods:
  − Open-label treatment period: 78 weeks with 4 on-site visits, which are scheduled every 6 months with remote visit/phone call in between (every 3 months)
  − Remote Onsite Safety follow-up period: 4 weeks after the last intake of filgotinib (1 visit)

  All participants will receive the study drug orally. The dose participants will get depends on weight.
  If participants weigh,
  • 15 to less than or equal 20 kilogram (kg): participants will get 65 milligram (mg) of filgotinib a day, given as 26 minitablets
  • 20 to 50 kg: participants will get one tablet (pill) or minitablets of 100 mg of filgotinib a day
  • More than 50 kg: participants will get one tablet of 200 mg of filgotinib a day

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  26/LO/0075

• Date of REC Opinion

  2 Mar 2026

• REC opinion

  Further Information Favourable Opinion