Study to Measure Filgotinib in the Blood of Children and... | NCT06222034

ID	Type	Description	Link
2023-505844-21-00	EU Trial (CTIS) Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Filgotinib Dose A	Experimental	Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-<25 kg	Drug: Filgotinib
Filgotinib Dose B	Experimental	Dose B of filgotinib tablet for participants with BW ≥25-<60 kg	Drug: Filgotinib
Filgotinib Dose C	Experimental	Dose C of filgotinib tablet for participants with BW ≥60 kg	Drug: Filgotinib

Name	Type	Description	Arm Group Labels	Other Names
Filgotinib	Drug	Film-coated mini-tablets administered orally once daily	Filgotinib Dose A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration at steady state of filgotinib (Cmax,ss)		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Cmax,ss of GS-829845, major active metabolite		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Area under the plasma concentration-time curve over the dosing interval at steady state of filgotinib (AUC0-24,ss)		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
AUC0-24,ss of GS-829845, major active metabolite		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Area under the plasma concentration time curve over the dosing interval at steady state or the effective exposure of filgotinib (AUCeff,ss)		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
AUCeff,ss of GS-829845, major active metabolite		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs), TEAEs of interest, serious TEAEs, and TEAEs leading to treatment discontinuation.		Baseline (Day 1) up to week 96
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).

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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.
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.

Key Exclusion Criteria:

Participant with persistent oligoarthritis.
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).

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens - Hopital Nord	Recruiting	Amiens		80054	France
Bicêtre University Hospital

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases