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

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

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

Treatments tested in this trial

  • Filgotinib
  • Filgotinib

Treatment groups

10 Participants
are divided into 3 treatment groups

Sponsors and collaborators