Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)

ConditionJuvenile Idiopathic Arthritis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age8-18

SponsorAlfasigma S.p.A.

About this trial

A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Filgotinib
Drug
Film-coated mini-tablets administered orally once daily
Filgotinib
Drug
Commercially developed film-coated tablet administered orally once daily

Treatment groups

10 Participants

are divided into 3 treatment groups

Group A: Filgotinib Dose AExperimental treatment 1 intervention

Group B: Filgotinib Dose BExperimental treatment 1 intervention

Group C: Filgotinib Dose CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum observed plasma concentration at steady state of filgotinib (Cmax,ss)

Time frame

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

Time frame

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)

Time frame

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

Time frame

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

Number of participants with treatment-emergent adverse events (TEAEs), TEAEs of interest, serious TEAEs, and TEAEs leading to treatment discontinuation.

Time frame

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).

Time frame

Week 4 and week 12