Active not recruitingPHASE3INTERVENTIONAL

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

This research study is investigating a new oral medication called baricitinib for children and young people aged 2 to 17 who have a type of eye inflammation called uveitis. Specifically, it's for those with uveitis linked to juvenile idiopathic arthritis (JIA) or a chronic form of uveitis positive for antinuclear antibodies. The main goal is to find out if baricitinib is a safe and effective treatment for these eye conditions. Researchers will compare baricitinib to another existing treatment, adalimumab. This study is important because it could offer a new option for young patients who haven't found enough relief from current treatments. Your participation could help improve care for many others in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

Start

16 Oct 2019

Estimated completion

01 Jul 2028

Uveitis

Results

Results from this study

Posted August 2024

Results have been published for this study.

Primary outcome

Part A: Percentage of Responders for Baricitinib at Week 24

Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.

Full results on the registry

What is this study about?

This study, called a Phase 3 trial, is looking into a new medicine called baricitinib. We want to see if it can help children and young people, from 2 to 17 years old, who are living with a specific eye condition called uveitis. Uveitis is when the middle layer of your eye becomes inflamed, which can cause pain, redness, blurred vision, and sometimes lead to more serious problems if not treated.

Specifically, this study focuses on two types of uveitis: one that's connected to juvenile idiopathic arthritis (JIA), which is a form of arthritis in children, and another type called chronic anterior antinuclear antibody-positive uveitis. We're testing baricitinib to see if it's safe to use and if it effectively reduces the inflammation in the eye. Currently, many children with these conditions use eye drops and other medicines like methotrexate, but sometimes these don't work well enough.

By taking part, you would be helping doctors understand if baricitinib could be a good new treatment option for young people who haven't found enough relief from their current medications. Your involvement is really valuable and could make a big difference in improving the lives of children and teenagers with uveitis.

Key takeaways

This study is for children and young people aged 2 to 17 with specific types of uveitis.
It's testing a new oral medicine called baricitinib against an existing injectable medicine, adalimumab.
The main goals are to check if baricitinib is safe and effective for active eye inflammation.
Participation involves regular clinic visits, eye exams, and blood tests.
You'll receive close medical attention throughout the study.
You can decide to leave the study at any time without affecting your usual care.

Who may be eligible?

To be considered for this study, participants must be between 2 and 17 years old and have a diagnosis of uveitis that is either linked to juvenile idiopathic arthritis (JIA) or is a chronic anterior antinuclear antibody (ANA) positive type without other widespread body issues. Your eye doctor must confirm that you currently have active inflammation in the front part of your eye, even if you've already been using steroid eye drops and methotrexate.

It's important that you haven't responded well to methotrexate or perhaps couldn't tolerate it. You should also be on a steady dose of corticosteroid eye drops (no more than 4 drops per day per eye for at least two weeks) before the study starts. If you or your partner can have children, you must agree to use two reliable forms of birth control throughout the study and for at least one week after the last dose of the study medicine.

There are also some reasons why someone might not be able to join. For example, if you have other autoimmune conditions like Crohn's disease, or if you've had certain eye surgeries recently (within the last 3 months). You also can't have a current infection, positive test for hepatitis B, or very high pressure in your eye that needs immediate treatment. If you have any questions about these, your doctor can help explain them.

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 2 and 17 years old?
Do you have uveitis linked to juvenile arthritis or chronic ANA-positive uveitis?
Is your uveitis currently active, despite using steroid eye drops and methotrexate?
Have you had problems with methotrexate or found it didn't work well enough?
Are you able to commit to the study's visit schedule and use birth control if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive either baricitinib or adalimumab, both of which are medicines designed to reduce inflammation. Baricitinib is taken as a pill by mouth, while adalimumab is given as an injection.

You would have regular visits to the clinic so the study team can monitor your eyes and overall health closely. These visits will involve eye exams, blood tests, and discussions about how you're feeling and if you're experiencing any side effects. The exact number and frequency of visits, as well as the total length of your participation, will be explained in detail by the study team. They will also tell you about any follow-up appointments after you stop taking the study medication. It's really important to follow the safety instructions and attend all your appointments during this time.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving close medical attention for your uveitis and potentially benefiting from a new treatment if current ones haven't been fully effective. However, like all medicines, both baricitinib and adalimumab can have side effects. These risks will be fully explained to you before you decide to join, and your health will be carefully monitored throughout the study. Remember, joining any study is completely voluntary, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (20)

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

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France
Hôpital Universitaire Necker Enfants Malades
Verified postcode
Paris, France
Centre Hospitalier Universitaire de Poitiers
Verified postcode
Poitiers, France
Asklepios Klinik Sankt Augustin
Verified postcode
Sankt Augustin, Germany
HELIOS Klinikum Berlin-Buch
Verified postcode
Berlin, Germany
Charité Campus Virchow-Klinikum
Verified postcode
Berlin, Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Verified postcode
Hamburg, Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Verified postcode
Milan, Italy
Azienda Ospedaliero Universitaria Meyer
Verified postcode
Florence, Italy
Hospital Sant Joan de Déu
Verified postcode
Esplugues de Llobregat, Spain
Hospital Infantil Universitario Niño Jesús
Verified postcode
Madrid, Spain
Hospital Universitario La Paz
Verified postcode
Madrid, Spain

Common questions

What is uveitis?

Uveitis is a condition where the middle layer of your eye becomes inflamed. It can cause redness, pain, blurry vision, and light sensitivity.

What is baricitinib?

Baricitinib is a medicine given by mouth that is being studied to see if it can help reduce the inflammation in your eyes caused by uveitis.

Will I have to have injections?

Some participants in this study may receive adalimumab, which is given as an injection. Others will receive baricitinib, which is taken as a pill.

How long will the study last?

The study team will explain the full expected duration of your participation, including the treatment period and any follow-up appointments.

What if I get worse during the study?

Your health will be closely monitored by the study team. If you feel unwell or your condition worsens, you should tell them immediately. You can also withdraw from the study at any time.