Active not recruitingPHASE3INTERVENTIONAL

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

This research study is looking into a new medicine, ixekizumab, for children and young people aged 2 to 17. It's for those with two specific types of juvenile arthritis: enthesitis-related arthritis (which includes a type of arthritis that can affect the spine called juvenile onset ankylosing spondylitis) and juvenile psoriatic arthritis. The main goal is to find out if ixekizumab is safe for these children and if it works well to help manage their arthritis symptoms. To understand its effects, we will be comparing it to another medicine, adalimumab, which is often used for these conditions. This is a Phase 3 study, meaning it's one of the final steps before a medicine might become more widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

101

Start

13 Apr 2021

Estimated completion

01 Apr 2028

Juvenile Psoriatic Arthritis Enthesitis Related Arthritis

What is this study about?

Imagine you have persistent joint pain, swelling, or stiffness, especially in places where tendons or ligaments attach to bones, or along with skin problems. This is a reality for children and young people with certain types of juvenile arthritis. This study focuses on two specific kinds: enthesitis-related arthritis and juvenile psoriatic arthritis. These conditions can be very challenging, affecting daily life, school, and play, and they can sometimes lead to long-term problems if not managed well. Current treatments help manage the symptoms, but researchers are always looking for even better options that are safe and effective for children.

That's where this study comes in. We want to explore a new medicine called ixekizumab. This medicine works by targeting specific parts of the immune system that cause inflammation in these arthritis conditions. By doing so, it aims to reduce pain, swelling, and other symptoms, helping children feel better and improve their overall health and well-being.

We will be comparing ixekizumab with another medicine called adalimumab, which is already used for these conditions. This comparison helps doctors understand if ixekizumab is as good as, or perhaps even better than, existing treatments. The information gathered from studies like this is crucial for doctors to make informed decisions about the best ways to treat children with these challenging forms of arthritis in the future.

Key takeaways

Study for children aged 2-17 with specific types of juvenile arthritis.
Testing a new medicine, ixekizumab, against an existing one, adalimumab.
Aims to check if ixekizumab is safe and effective in reducing arthritis symptoms.
Involves regular clinic visits and close health monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children and young people between the ages of 2 and 17 years old. To join, they must have either active enthesitis-related arthritis (which sometimes includes juvenile onset ankylosing spondylitis) or active juvenile psoriatic arthritis. They also need to weigh at least 10 kilograms. If they have juvenile psoriatic arthritis, they must be at least 2 years old, and if they have enthesitis-related arthritis, they must be at least 6 years old. It's also important that all their routine childhood vaccinations are up-to-date, as advised by your doctor.

There are also some reasons why someone might not be able to join the study. For example, if they have certain other health problems like inflammatory bowel disease, an active eye condition called uveitis, or an active infection. They also cannot have ever had or currently have tuberculosis. If your child is already taking certain types of biological medicines for their arthritis, they wouldn't be able to join this study either.

The research team will carefully check all these requirements to make sure the study is a good fit for your child and that it would be safe for them to take part.

Quick self-check

Is your child aged between 2 and 17 years old?
Does your child have active enthesitis-related arthritis or juvenile psoriatic arthritis?
Does your child weigh at least 10 kilograms?
Are your child's routine vaccinations up-to-date?
Does your child currently NOT have any active infections or other specific serious health conditions mentioned by the study team?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, the study team would perform various assessments to check your child's health and how their arthritis is responding to the treatment. This might include physical examinations, blood tests, and potentially other tests related to their arthritis. Your child would receive either the new study medicine, ixekizumab, or the comparison medicine, adalimumab. The treatments are usually given as an injection. The study team would explain exactly how and when to give the medicine. Throughout the study, the team would closely monitor your child for any side effects and to see how their arthritis symptoms are changing. After the main treatment period, there will be follow-up visits to continue to monitor their health. The total time your child would be involved in the study would depend on the specific study plan, which the research team would discuss with you in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new medicine that could improve your child's arthritis symptoms, and close medical monitoring by experts. However, like all medicines, ixekizumab and adalimumab can have side effects, and there's no guarantee that the treatment will help everyone. The research team will explain all the known and potential risks in detail. It's important to remember that your child's participation is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (43)

Instituto CAICI SRL Loc. 15
Rosario, Argentina
Centro Medico Privado de Reumatologia Loc. 20
San Miguel de Tucumán, Argentina
Cliniques universitaires Saint-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Oddeleni revmatologie deti a dospelych Loc. 1
Prague, Czechia
Dětská klinika Loc. 11
Olomouc, Czechia
Klinika detskeho a dorostoveho lekarstvi Loc. 1
Prague, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, Denmark
Service rhumatologie Loc.
Bron, France
Service de consultation pédiatrique Loc. 1
Montpellier, France
Rhumatologie pediatrique et CEREMAIA Loc. 1
Le Kremlin-Bicêtre, France

+31 more sites — see the official record for the full list.

Common questions

What is juvenile idiopathic arthritis?

Juvenile idiopathic arthritis (JIA) is a type of long-term arthritis that affects children and young people under the age of 16. It causes joint pain, swelling, and stiffness.

What are enthesitis-related arthritis and juvenile psoriatic arthritis?

These are two specific types of juvenile idiopathic arthritis. Enthesitis-related arthritis mainly affects places where tendons and ligaments attach to bones, while juvenile psoriatic arthritis occurs in children who also have a skin condition called psoriasis.

What is ixekizumab?

Ixekizumab is a new medicine being tested. It works by calming down parts of the immune system that cause inflammation in arthritis, aiming to reduce pain and swelling.

What is adalimumab?

Adalimumab is an existing medicine commonly used to treat certain types of arthritis, including some forms of juvenile idiopathic arthritis. It also works by affecting the immune system.

Will my child definitely get the new medicine?

This is a comparison study, so your child might receive either ixekizumab (the new medicine) or adalimumab (an existing medicine). The study team will explain how this is decided.