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

Alfasigma

Status and phase: Enrolling; Phase 1

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: Filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06222034

GLPG0634-CL-131

2023-505844-21-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Filgotinib Dose A

Experimental group

Description:

Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\<25 kg

Treatment:

Drug: Filgotinib

Drug: Filgotinib

Filgotinib Dose B

Experimental group

Description:

Dose B of filgotinib tablet for participants with BW ≥25-\<60 kg

Treatment:

Drug: Filgotinib

Drug: Filgotinib

Filgotinib Dose C

Experimental group

Description:

Dose C of filgotinib tablet for participants with BW ≥60 kg

Treatment:

Drug: Filgotinib

Drug: Filgotinib