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

Launched by ALFASIGMA S.P.A. · Jan 15, 2024

Keywords

ClinConnect Summary

The SCALESIA study is a clinical trial designed to understand how well a medication called Filgotinib works in the blood of children and teenagers with a condition called Juvenile Idiopathic Arthritis (JIA). This trial aims to evaluate how safe Filgotinib is and how well it can be tolerated by young patients who have not responded well to their current treatments. The trial is currently looking for participants aged between 2 and 18 years who have specific types of arthritis and meet certain health criteria.

To be eligible for this study, participants need to weigh at least 15 kg and have a certain body weight range for their age and gender. They should also have a diagnosis of JIA that is moderately to severely active and not well-controlled with current medications. Participants can expect to be closely monitored throughout the trial, which will help researchers gather important information about the medication’s effects. It's important to note that there are some health conditions that could prevent someone from joining the study, such as ongoing infections or other serious diseases. If you think you or your child might be eligible, this trial could be an opportunity to help improve treatment options for young people with arthritis.

Gender

ALL

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.