RecruitingPHASE1INTERVENTIONAL

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

This research, called SCALESIA, is for children and teenagers aged 8 to 18 who have Juvenile Idiopathic Arthritis (JIA). We want to understand how a medicine called filgotinib moves through their bodies and how quickly it's removed. This is important for finding the right dose for young people. We're also checking how safe the medicine is and if they have any side effects. The goal is to see if filgotinib could be a helpful treatment for JIA, especially for those whose current treatments aren't working well enough. This is an early stage study (Phase 1) focused on understanding the medicine's behaviour in the body.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Alfasigma S.p.A.

Enrolment target

Start

13 May 2024

Estimated completion

01 Aug 2026

Juvenile Idiopathic Arthritis

What is this study about?

This study, called SCALESIA, is looking into a new medicine named filgotinib for children and teenagers who have a type of arthritis called Juvenile Idiopathic Arthritis, or JIA. JIA can cause pain, swelling, and stiffness in joints, making everyday activities difficult for young people.

The main goal of this study is to understand how filgotinib works inside the bodies of young people. This includes finding out how much of the medicine gets into their blood, how long it stays there, and how their bodies get rid of it. This information is really important because it helps doctors figure out the best and safest dose for children and teenagers, which can be different from adults.

We also want to make sure that filgotinib is safe for young people with JIA and to see if they experience any side effects. By learning more about this medicine, we hope to potentially offer a new treatment option for children and teenagers whose JIA isn't well controlled by their current medicines.

Key takeaways

This study is for children and teenagers with Juvenile Idiopathic Arthritis (JIA).
It aims to understand how a medicine called filgotinib works in their bodies.
Researchers will check the medicine's safety and how it is processed by the body.
Participants must have JIA that isn't well controlled by current treatments.
This is an early-stage study to gather important information about filgotinib.

Who may be eligible?

This study is looking for children and teenagers aged 8 to 18 who have been diagnosed with Juvenile Idiopathic Arthritis (JIA). It's important that your JIA is currently active and hasn't improved enough with other medicines you've already tried. This includes medicines like methotrexate or other common arthritis treatments.

To be considered, you should also be within a healthy weight range for your age and sex, and weigh at least 15 kilograms (about 33 pounds). If you're a girl who has started your period, you'll need to have a negative pregnancy test first.

There are also some reasons why you wouldn't be able to join. For example, if you have other ongoing serious health problems like certain long-term infections, other specific immune system conditions, or if your JIA is a very specific type that affects only a few joints for a long time. The study doctor will carefully review your health to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 8 and 18 years old?
Do you have Juvenile Idiopathic Arthritis (JIA)?
Has your JIA not improved enough with other medicines you've tried?
Do you meet the weight requirements (at least 15 kg)?
Are you, or your child, generally healthy apart from JIA?
If female and started periods, are you able to provide a negative pregnancy test?

Answer every question to see your result.

What does participation involve?

The detailed information about what participating involves is not fully provided in this summary. However, typically in studies like this, if you join, you would likely have several visits to the clinic or hospital. These visits would include blood tests to measure the medicine levels, physical check-ups to assess your arthritis, and discussions about any side effects you might be experiencing. You would be given the study medicine, filgotinib, according to a schedule decided by the study doctors. There would be regular follow-up visits to monitor your health and the medicine's effects. The total duration of your participation would be confirmed by the study team, but these types of studies often last for several months.

Potential risks and benefits

Taking part in a study like this could potentially offer personal benefits, such as receiving a new medicine for your JIA that might help if your current treatments aren't working. It also helps advance medical knowledge for other young people with JIA. However, like all medicines, filgotinib may have side effects, which the study team will monitor closely. There are also risks associated with study procedures, such as blood draws. You are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

CHU Amiens - Hopital Nord
Verified postcode
Amiens, France· Recruiting
Bicêtre University Hospital
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
Children's university hospital Charité, Campus Virchow, SPZ
Verified postcode
Berlin, Germany· Recruiting
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Verified postcode
Hamburg, Germany· Recruiting
Asklepios Klinik Sankt Augustin GmbH
Verified postcode
Sankt Augustin, Germany· Not yet recruiting
Malopolskie Badania Kliniczne
Verified postcode
Krakow, Poland· Recruiting
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain· Recruiting
Hospital Sant Joan de Deu
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitari i Politecnic La Fe
Verified postcode
Valencia, Spain· Recruiting
Great Ormond Street Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is Juvenile Idiopathic Arthritis (JIA)?

JIA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness.

What is filgotinib?

Filgotinib is a medicine being tested to see if it can help treat JIA.

Why is this study only for 8 to 18-year-olds?

This study focuses on this age group to understand how the medicine works specifically in younger, developing bodies.

Will I know if I'm getting the real medicine?

In some studies, participants might not know if they are getting the study medicine or a placebo, but this study is about understanding how the actual medicine works, so you would likely receive filgotinib.

What if my JIA gets worse during the study?

The study doctors will monitor your health closely, and if your condition worsens or if there are any concerns, they will discuss your treatment options with you.

How to find out more

Pilar de la Torre

medicalinfo@alfasigma.com 00800 7878 1345 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.