FILGOTINIB for Juvenile idiopathic arthritis

Inclusion criteria

• {"criterion_text":"- Subject must have completed treatment with filgotinib in at least one parent study (GLPG0634-CL-131, GLPG0634-CL-329, or GLPG0634-CL-328) and achieved a clinical benefit at the end of the parent protocols.\n- 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 informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/Institutional Review Board, prior to any protocol evaluations.\n- Female or male subject 8 to <18 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/preventive exposure measures as described in the clinical study protocol."}

Exclusion criteria

• {"criterion_text":"- 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 judgment.\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."}

Primary endpoints

• {"endpoint_text":"- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.","definition_or_measurement_approach":"Assessed at each visit throughout the duration of the study (frequency and severity of TEAEs, SAEs, and TEAEs leading to treatment discontinuation)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of subjects with JIA ACR inactive disease.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of subjects with JIA ACR clinical remission over time.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of treatment-emergent uveitis (including severity).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of response.","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

24-02-2026

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

36

Number Of Sites

1

Number Of Participants

9

Germany

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

47

Number Of Sites

2

Number Of Participants

9

Primary sponsor

Full Name

Alfasigma S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Suvoda LLC

Responsibilities

sponsorDuties code: 3

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties code: 7

Name

Quipment

Responsibilities

sponsorDuties code: 15; supply of pregnancy kits

Name

IQVIA Limited

Responsibilities

sponsorDuties codes: 1,10,11,12,15 (Medical monitoring),2,5,6; medical monitoring noted

Name

Almac Clinical Services Limited

Responsibilities

sponsorDuties code: 15; Medicinal product production, QP certification and release, overall distribution and destruction of reconciled IMP

Third parties

• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Quipment","duties_or_roles":"sponsorDuties code: 15; value: supply of pregnancy kits","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 10, 11, 12, 15 (Medical monitoring), 2, 5, 6; value noted for code 15: Medical monitoring","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties code: 15; value: Medicinal product production, QP certification and release, overall distribution and destruction of reconciled IMP","organisation_type":"Pharmaceutical company"}