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

Sponsor
Alfasigma S.p.A.
Study ID
NCT06222034
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Filgotinib — DRUG
    Film-coated mini-tablets administered orally once daily
  • Filgotinib — DRUG
    Commercially developed film-coated tablet administered orally once daily

Study Details

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

Key Dates

Start date
May 13, 2024
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Filgotinib Dose A
    Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\<25 kg
  • Experimental: Filgotinib Dose B
    Dose B of filgotinib tablet for participants with BW ≥25-\<60 kg
  • Experimental: Filgotinib Dose C
    Dose C of filgotinib tablet for participants with BW ≥60 kg

Primary Outcome Measure

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 ]

Central Contacts

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